URGENT FIELD SAFETY NOTICE - Flowonix

1 Approval Date: October 2019

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URGENT FIELD SAFETY NOTICE

Prometra® Programmable Pump System

RECIPIENTS: Health Care Providers using Prometra® and Prometra® II

Programmable Pumps

08 October 2019

Product Name: Prometra® Programmable Pump System

Catalog No.: Prometra® Pump - REF 91827

Prometra® II Pump - REF 93827

Type of Action: Labeling Changes:

Prometra (I) Pump REF 91827- MR Category Changed to MR Unsafe Prometra II Pump REF 93827- Revised MR Scan Parameters

Dear Physician:

Flowonix Medical, Inc. is distributing a Field Safety Notice to ensure all European

Healthcare Providers and their associated MRI centers are aware of the latest EU MRI

scanning instructions associated with the Prometra Pump Systems and to distribute

revised labeling which includes up-to-date scanning parameters for the Prometra® II

Programmable Pump.

Prometra® (I) Programmable Pump (REF 91827)

Until this time the Prometra® (I) Programmable Pump (REF 91827) had been labeled “MR

Conditional”, and required that all drug be removed from the pump prior to an MRI to

prevent the risk of drug overdose due to the possibility of both the inlet and outlet valves

opening in a strong magnetic field. Unlike the Prometra II Programmable Pump (REF

93827) which contains a Flow Activated Valve (FAV) that reduces this risk, the Prometra

(I) Pump does not have the FAV safety feature. Post-market surveillance data has


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demonstrated that due to user error, the Instructions for Use have not been followed and

patient injury has been reported. Therefore the Prometra (I) Pump labeling is being

changed to “MR Unsafe” to further reduce the risk of user error and non-compliance with

the drug removal safety instructions. The Prometra® (I) Programmable Pump (REF

91827) is no longer CE marked and is not available for new patients, however, there are

patients in the EU who are currently implanted with this model.

Prometra® II Programmable Pumps (REF 93827)

The Prometra® II Programmable Pumps (REF 93827) remain categorized as MR

Conditional, based on MRI compatibility testing. To maintain compliance with the most

current MRI compatibility standard, Flowonix recently tested the Prometra pump to the

latest new industry standard. As a result of applying extremely conservative, non-clinical

testing parameters, as mandated by the new testing standard, the MRI Safety Information

provided in the pump Instruction for Use have been updated.

The following are the updated scanning parameters for the MR Conditional Prometra® II

Programmable Pumps (REF 93827). Please review the Prometra® MRI Reference Guide:

MRI Conditions for Safe Scanning for the Prometra Intrathecal Pump; PL-71802-00

provided in Attachment 1.

SCANNING PARAMETERS Non-clinical testing has demonstrated that the Prometra II Programmable Pump is

MR Conditional. A patient with this device can be safely scanned in an MR system

meeting the following conditions:

1. Horizontal, cylindrical, closed-bore MRI scanner

2. Maximum static magnetic field of 1.5 Tesla

3. Maximum spatial field gradient of 400 gauss/cm (4 T/m) Warning: Exceeding the 400 gauss/cm (4 T/m) at 1.5 T limit could result in

excessive force or torque which could lead to patient injury.

4. Maximum MR System reported, whole body averaged specific absorption rate (SAR) of < 2 W/kg (Normal Operating Mode) using scanner’s transmit/receive body coil.

5. Maximum gradient slew rate of 200 T/m/s.

6. Scan duration should be limited to 10 minutes per pulse sequence.

7. Patients must only be scanned in a supine position.

8. The implant should be no more than 15 cm from the scanner z-axis (central axis of the scanner bore).

9. All Pre-MRI Instructions must be completed.

10. Use of local transmit-receive RF coils in the vicinity of an implanted Prometra® II


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Programmable Pump has not been evaluated and should be avoided, including but not limited to:

• RF transmit-receive Head coil

• RF transmit-receive Lower extremity coil

• RF transmit-receive Upper extremity coil

Warning: Do not place a local RF transmit coil directly over any part of an

implanted Prometra® II Programmable Pump

11. The head SAR must be ≤ 3.2 W/kg

12. Patient does not have elevated body temperature or compromised thermoregulation at time of scan.

13. Patients must be continuously monitored for the duration of their exposure to the MR environment.

Risk to Health: MR Unsafe for Prometra Programmable Pump (REF 91827): The Prometra (I)

Programmable Pump does not contain a Flow Activated Valve (FAV) that reduces the risk

of drug overdose in the event of user error where a patient is exposed to an MR field

without having the drug removed from the pump. Therefore the Prometra (I) Pump

labeling has been changed to “MR Unsafe”.

MR Conditional for Prometra II Programmable Pump (REF 93827): The MRI scan

parameters and associated labeling have been updated to reflect conclusions drawn from

“state of the art” MRI test results so patients can be safely scanned without unacceptable

levels of heating, vibration, induced voltage, malfunction, displacement, or torque.

Actions to be Taken by Physicians

1. Read the Prometra® MRI Reference Guide: MRI Conditions for Safe Scanning for

the Prometra Intrathecal Pump; PL-71802-00; Attachment 1 of this letter. This

document is also available at www.flowonix.com. The full Instructions for Use for

the Prometra and Prometra II Pumps are also available online.

a. Prometra Programmable Pump Instructions for Use, PL-91791 b. Prometra II Programmable Pump Instructions for Use, PL-71800

2. For Prometra II patients requiring an MRI procedure, ensure that the patient is

safely scanned in an MR system by following the latest scanning parameters.

3. For Prometra (I) patients ensure that patients are made aware that the Prometra (I)

Pump labeling is being changed to “MR Unsafe”.

http://www.flowonix.com/


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a. Provide all Prometra (I) patients with a revised Patient Guide; PL-819132-

03 provided in Attachment 2.

b. Provide all Prometra (I) patients with a revised temporary patient ID card;

(PL-82375-04) provided as Attachment 3.

4. Physicians and associated MRI centers: Forward this Field Safety Notice information to patients, staff, and all those who need to be aware of the latest MRI scanning instructions associated with the Prometra Pump Systems within your organization.

5. Acknowledgement Response Form: Promptly complete the Physician- Urgent Field Safety Notice Response Form PL-71205-00 provided in Attachment 4 and return it to Flowonix Medical as per the instructions on the form.

Should you have concerns or require further clarification, please contact your Flowonix Representative or our Technical Solutions Department (+1 844-229-6729). Thank you for your cooperation.

Sincerely,

Karen E. Matis, RAC, CCRA

Senior Vice President

Clinical, Quality & Regulatory Affairs

Flowonix Medical, Inc.

Attachments: Attachment 1: Prometra® MRI Reference Guide: MRI Conditions for Safe Scanning for the

Prometra Intrathecal Pump; PL-71802-00 (English) Attachment 2: Patient Guide; PL-81912-03 Attachment 3: Prometra (l) Temporary Patient ID Card; PL-82375-04 Attachment 4: Physician - Field Safety Notice Response Form; PL-71205-00

jcarpenter

Stamp

Attachment 1: Prometra® MRI Reference Guide: MRI Conditions for Safe Scanning

for the Prometra Intrathecal Pump; PL-71802-00 (English)

Page 1 of 13

PROMETRA® MRI REFERENCE GUIDE: MRI CONDITIONS FOR SAFE SCANNING FOR THE PROMETRA INTRATHECAL PUMP

IMPORTANT INFORMATION FOR CLINICIANS, MRI OPERATORS AND PATIENTS

For full instructions, warnings and precautions related to the Prometra Programmable Pump System, please refer to the complete Prometra Pump Instructions for Use

NOTE: The Prometra Programmable Infusion System includes two separate models of pump, which have DIFFERENT MRI Safety Information. Please identify the appropriate model and follow the MRI Safety Information provided in this document.

Pump Model REF MRI Category

Prometra 91827

MR Unsafe

Prometra II 93827

MR Conditional

Prometra® Programmable Pump (REF 91827) Magnetic Resonance Imaging (MRI) Safety Information

MR Unsafe

The Prometra Programmable Pump (REF 91827) is MR Unsafe.

WARNING: EXPOSURE TO MRI ENVIRONMENT WITH PROMETRA PUMP COULD RESULT IN DRUG OVERDOSE THAT COULD LEAD TO SERIOUS PATIENT INJURY OR DEATH.

Page 2 of 13

Prometra® II Programmable Pumps (REF 93827) Magnetic Resonance Imaging (MRI) Safety Information

GENERAL MR Conditional

WARNING: FAILURE TO EMPTY THE PUMP PRIOR TO EXPOSURE TO MRI ENVIRONMENT COULD RESULT IN DRUG OVERDOSE THAT COULD LEAD TO SERIOUS PATIENT INJURY OR DEATH.

Warning: Patients should not be exposed to MRI environments until the surgical site

following pump implantation is fully healed.

Warning: EMPTY ALL DRUG SOLUTION FROM PROMETRA II PUMPS PRIOR TO ENTERING

THE MRI ENVIRONMENT. Strong magnetic fields, such as those created in MRI scanners,

may cause the Inlet and Outlet Valves to open, resulting in the immediate discharge of

the contents of the Drug Reservoir and Catheter into the patient. This could result in drug

overdose that could lead to serious patient injury or death. If a patient with a Prometra II

Pump requires an emergent MRI, please see page 6 of these instructions for more details

on the potential risks involved.

Prior to initiating the MRI procedure, the physician must determine if the patient can safely be

deprived of medication for the length of the MRI procedure. If medication is needed, then alternate

means of drug delivery (such as I.V. administration) should be employed for the duration of the MRI

procedure.

Prior to scheduling an MRI scan and upon its completion, pump status should be confirmed by

inquiring the pump to verify pump operation and settings.

Note: Pre-MRI, Post-MRI, and Medical Emergency Use instructions are provided in this document.

SCANNING PARAMETERS Non-clinical testing has demonstrated that the Prometra II Programmable Pumps are MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:

1. Horizontal, cylindrical, closed-bore MRI scanner

2. Maximum static magnetic field of 1.5 Tesla

3. Maximum spatial field gradient of 400 gauss/cm (4 T/m)

Warning: Exceeding the 400 gauss/cm (4 T/m) at 1.5 T limit could result in excessive force or torque which could lead to patient injury.

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4. Maximum MR System reported, whole body averaged specific absorption rate (SAR) of < 2 W/kg (Normal Operating Mode) using scanner’s transmit/receive body coil.

5. Maximum gradient slew rate of 200 T/m/s.

6. Scan duration should be limited to 10 minutes per pulse sequence.

7. Patients must only be scanned in a supine position if the pump is located in the abdomen, such that the pump will be no more than 15 cm from the scanner z-axis (central axis of the scanner bore). If the pump is not located in the abdomen, patients must be scanned in a position such that the pump will be no more than 15 cm from the scanner z-axis.

8. Prior to placing the patient in the MR environment, the MR technician should use visual examination as well as palpation to verify the exact location of the pump.

9. All Pre-MRI Instructions must be completed.

10. The use of local transmit-receive RF coils in the vicinity of an implanted Prometra® II Programmable Pump has not been evaluated and should be avoided, including but not limited to:

• RF transmit-receive Head coil

• RF transmit-receive Lower extremity coil

• RF transmit-receive Upper extremity coil

Warning: Do not place a local RF transmit coil directly over any part of an implanted Prometra® II Programmable Pump

Page 4 of 13

11. The head SAR must be ≤ 3.2 W/kg

12. Patient does not have elevated body temperature or compromised thermoregulation at time of scan.

13. Patients must be continuously monitored for the duration of their exposure to the MR environment.

NOTE: The MRI conditions for safe scanning detailed in this document only pertain to

the Prometra Pumps implanted in the abdomen. Testing has not been conducted in other

implantation locations or in the presence of other implanted active or passive medical

devices. Other implanted devices (such as pacemakers, abandoned leads, knee implants,

etc.) could have conflicting MR conditions which could lead to patient injury or device

malfunction.

Tissue Heating Adjacent to Implant during MR Scans

The local temperature increase produced by the pump is considered to be below level of concern. In

the unlikely event that the patient experiences uncomfortable warmth near the pump, the MRI scan

should be stopped and the scan parameters adjusted to reduce SAR to comfortable levels.

Warning: Static Magnetic Field

In a 1.5 Tesla MR environment, the pump has a significant magnetically induced deflection

force and very strong torque. The static and gradient magnetic fields produced by an MRI

scanner could potentially interact with the pump and cause vibration. However, when

pumps are implanted with proper techniques, the patient may safely be scanned under

the conditions listed above. Not following the specific conditions may result in serious

patient injury. The patient may experience a tugging and/or vibration sensation at the

implant site when placed within the magnetic field. An elastic garment or wrap will help

restrict movement and reduce these sensations while the patient is in the magnetic field.

Image Artifacts

The programmable pump contains ferromagnetic components that will cause image distortion and

localized voids in regions of the image around the pump. MR image quality will be compromised if the

area of interest is near the pump.

In non-clinical testing, the image artifact caused by Flowonix Medical’s Prometra II 20 mL Pumps

extends greater than 18.5 cm from the device when imaged with a spin-echo or gradient-echo pulse

sequence in a 1.5 T MRI system. Image artifacts may be reduced when sequences are optimized for

imaging (e.g. shorter echo time, decreased water fat shift, etc.). Images of the head and lower

extremities away from the location of the Prometra Pump should be largely unaffected.

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SPECIFIC PRE-MRI INSTRUCTIONS


Prometra® II (REF 93827) Programmable Pumps

Protocol for Prometra® II (REF 93827) Programmable Pumps Pre-MRI Procedure

Warning: EMPTY ALL DRUG SOLUTION FROM PROMETRA II PUMPS PRIOR TO ENTERING

THE MRI ENVIRONMENT. Strong magnetic fields, such as those created in MRI scanners,

may cause the Inlet and Outlet valves to open, resulting in the immediate discharge of

the contents of the Drug Reservoir and Catheter into the patient. This could result in drug

overdose that could lead to serious patient injury or death. If a patient with a Prometra II

Pump requires an emergent MRI, please see page 6 of these instructions for more details

on the potential risks involved.

The physician must determine if the patient can safely be deprived of medication during the MRI

procedure. If medication is needed then alternative means of drug delivery (such as I.V.

administration or analgesic patch) should be employed.

IF AN MRI PROCEDURE IS NECESSARY, THE PUMP MUST BE EMPTIED of drug solution, not refilled and the PUMP PROGRAMMED TO 0.0 MG/DAY DRUG FLOW RATE prior to entering the environment of the MRI. PERFORM THE FOLLOWING STEPS PRIOR TO ENTERING THE MRI ENVIRONMENT.

1. Pump Inquiry

Inquire the pump with the programmer to verify pump model, the pump is

operational and without errors. Print inquiry page.

2. Pump Programming

Set the flow mode to a constant flow rate of 0.0 mg/day. Re-inquire the pump and print inquiry

page to confirm a constant flow rate of 0.0 mg/day.

3. Empty Drug Reservoir

Follow the procedures for emptying the Drug Reservoir in the Refill Kit Instructions for Use.

WARNING: IF PUMP STATUS CANNOT BE PROPERLY CONFIRMED, DO NOT PROCEED SINCE THE PUMP MAY NOT BE OPERATING PROPERLY, PLEASE CONTACT FLOWONIX TECHNICAL SOLUTIONS FOR ASSISTANCE AT: +1 844-229-6729.

Page 6 of 13

SPECIFIC POST-MRI INSTRUCTIONS

Protocol for Prometra® II (REF 93827) Programmable Pumps Post-MRI Procedure

1. Confirm Pump Operational Status –

a. Inquire the pump with the programmer to verify pump operation and settings.

b. Confirm that settings are unchanged from the Pre-MRI settings, e.g., flow rate must be

0.0 mg/day.

c. If the programmer displays any pump errors, proceed to Step 2 “Clear Pump Errors”.

d. If no pump errors are displayed, proceed to Step 3 “Inlet and Outlet Valve Closure

Confirmation”.

2. Clear Pump Errors

a. If pump errors are displayed from the Inquiry performed in Step 1, perform an Emergency Pump Stop using the programmer, and contact Flowonix Technical Solutions for assistance +1 844-229-6729.

b. If pump errors are cleared, proceed to Step 3.

3. Confirm Inlet / Outlet Valve Closure

a. Attempt to aspirate the Drug Reservoir through the Refill Port. To aspirate, attach the

22G non-coring needle (available in Refill Kit) to a sterile syringe.

b. Advance needle through center Refill Port Septum until needle tip resides completely

inside the Drug Reservoir.

c. Pull a vacuum with the syringe for approximately 10 to 30 seconds to confirm Inlet / Outlet Valve closure.

Warning: If any significant volume (>1ml) is retrieved, it may be indicative that the pump

Inlet / Outlet Valves are open, providing direct access to the catheter/cerebral spinal

fluid; If so, DO NOT proceed with the refill since the pump may not be operating properly.

The pump may need to be explanted and replaced. For questions, Contact Flowonix

Technical Solutions for assistance at: +1 844-229-6729.

4. Refill The Drug Reservoir

a. Proceed to refill the Drug Reservoir in accordance with the refill procedure defined in

the Refill Kit Instructions for Use.

b. Confirm the correct prescription is programmed, or program a new prescription.

Warning: A period of observation should follow the Refill Procedure to closely monitor

patients for clinical symptoms of underdose or overdose based upon the drug’s

prescribing information.


Page 7 of 13

IN THE EVENT OF A MEDICAL EMERGENCY REQUIRING AN MRI SCAN:

Prometra® Programmable Pump (REF 91827)

MR Unsafe

The Prometra Programmable Pump (REF 91827) is MR Unsafe.

Prometra® II Programmable Pump (REF 93827)

In the event of a medical emergency requiring a STAT MRI, the treating physician must be aware of

the following as inputs to decision making regarding proceeding with an Emergency MRI for the

Prometra II Pump (REF 93827):

WARNING: In the event an MRI scan was performed on a patient with a Prometra® II Pump

where the drug was NOT removed due to a medical emergency situation, the Prometra® II

Pump contains a Flow Activated Valve (FAV) intended to reduce, but not eliminate, the risk

of drug overdose. A physician must evaluate the patient immediately for signs and

symptoms of drug overdose and develop a plan for immediate monitoring in a medically

supervised and adequately equipped environment. Resuscitative equipment should be

available, as should medications to manage drug overdose.

FLOWONIX STRONGLY RECOMMENDS THAT ALL DRUG BE REMOVED FROM THE PROMETRA® II DRUG RESERVOIR PRIOR TO ANY MRI SCAN.

The Prometra® II Pump includes a Flow Activated Valve (FAV) intended to reduce, but not eliminate, the risk of drug over-infusion during an MRI procedure. If the Drug Reservoir volume is ≤1mL or expected to be ≤1mL at the time of the Emergency MRI scan, do not proceed with an Emergency MRI scan without first emptying the drug from the Reservoir, If there is ≤1mL of drug in the Reservoir, the drug must be removed prior to the Emergency MRI procedure. When the Reservoir volume is at < 1 mL, the FAV may not close. Thus, the drug within the Reservoir may be bolused to the patient. This could result in drug overdose that could lead to serious patient injury or death. To determine the volume of drug in the Reservoir, inquire the pump

with a Prometra® Programmer. The Reservoir volume is shown on the inquiry screens. If a


Page 8 of 13

Programmer is not available, then all drug must be removed from the Drug Reservoir prior to the Emergency MRI scan.

The Flow Activated Valve (FAV) of the Prometra® II Pump is intended to shut off drug flow when

exposed to strong magnetic fields. When this occurs a small amount of drug, ≤10 μL, will be

delivered to the patient. The physician must determine if the patient can safely receive this 10 μL

bolus dose during the Emergency MRI procedure(1,2). If not, then all drug must be completely

emptied from the Drug Reservoir prior to the Emergency MRI procedure.

NOTE:

1. For a pump containing morphine at a concentration of 25 mg/mL, a bolus dose of < 0.25 mg would be delivered to the patient during an Emergency MRI procedure if the drug was not removed from the Drug Reservoir prior to the MRI.

2. For a pump containing baclofen at a concentration of 2 mg/mL, a bolus dose of < 20

µg would be delivered to the patient during an Emergency MRI procedure if the drug was not removed from the Drug Reservoir prior to the MRI.

Following an MRI, the FAV will be closed, and will prevent further drug delivery to occur until the

pump is manually reset after the completion of the MRI procedure. The physician must

determine if the patient can safely be deprived of medication until the FAV is reset after the

MRI procedure. If medication is needed, then alternate means of drug delivery (such as I.V.

administration or analgesic patch) should be employed keeping in mind that the patient will be

receiving up to a 10 μL bolus of drug during the Emergency MRI if drug was not removed from

the Reservoir prior to the MRI procedure.

In the event that an Emergency MRI scan was performed on a patient with a Prometra® II pump in

which the drug was NOT removed due to a medical emergency situation, the Prometra II FAV

must be reset by performing a reset procedure.

1 Per Deer et al., Polyanalygesic Consensus Conference 2012: Recommendation for the Management of Pain by Intrathecal (Intraspinal) Drug Delivery: Report of an Interdisciplinary Expert Panel, bolus doses of 5%-20% of the daily dose are typical, but cautions that doses are additive to baseline infusion and cumulative side effects could occur.

2 Lioresal (Baclofen Injection) Instructions for Use. Medtronic, Inc., Minneapolis, MN; Gablofen (Baclofen Injection) Instruction

for Use. Mallinckrodt Pharmaceuticals, Inc., Hazelwood, MO.

Page 9 of 13

Emergency Procedure PRE-MRI Steps for Prometra II Pump

1. Pump Inquiry

a. Inquire the pump with the programmer to verify pump model, the pump is

operational and without errors.

b. Verify that more than 1mL of drug is present in the Drug Reservoir.

c. Print inquiry page.

2. Pump Programming

a. Set the flow mode to a constant flow rate of 0.0 mg/day.

b. Re-inquire the pump and print inquiry page to confirm a constant flow rate of 0.0 mg/day.

Emergency Procedure POST-MRI Steps for Prometra II Pump

1. Confirm Pump Operational Status –

a. Inquire the pump with the programmer to verify pump operation and settings.

b. Confirm that settings are unchanged from the Pre-MRI settings, e.g., flow rate must be

0.0 mg/day.

c. If the programmer displays any pump errors, proceed to Step 2 “Clear Pump Errors”.

d. If no pump errors are displayed, proceed to Step 3 “FAV Reset Procedure”.

2. Clear Pump Errors

a. If pump errors are displayed from the Inquiry performed in Step 1, perform an Emergency Pump Stop using the programmer, and contact Flowonix Technical Solutions for assistance +1 844-229-6729.

b. If pump errors are cleared, proceed to Step 3.

3. FAV Reset Procedure

a. Remove drug from Drug Reservoir by aspirating through the Refill Port.

b. To aspirate, attach the 22G non-coring needle to a syringe barrel (available in Refill Kit).

c. Advance needle through the center Refill Port Septum until needle tip resides completely inside the Drug Reservoir.



Page 10 of 13

d. Empty the Drug Reservoir until there is no more fluid returning to the syringe barrel. (Refer to Refill Kit Instructions for Use for further details on emptying the pump).

e. After ensuring the Drug Reservoir is fully empty, program a Demand Bolus to deliver (0.03 mL x concentration) over 2 minutes (this will not dispense drug since the Drug Reservoir is empty).

f. Wait for the 2-minute Demand Bolus to complete before proceeding.

4. Confirm Inlet / Outlet Valve Closure

a. Attempt to aspirate the Drug Reservoir through the Refill Port. To aspirate, attach a

sterile syringe to the 22G non-coring needle used in Step 3c above.

b. Pull a vacuum with the syringe for approximately 10 to 30 seconds to confirm Inlet / Outlet Valve closure.

Warning: If any significant volume (>1ml) is retrieved, it may be indicative that the pump

Inlet / Outlet Valves are open, providing direct access to the catheter/cerebral spinal

fluid; If so, DO NOT proceed with the refill since the pump may not be operating properly.

The pump may need to be explanted and replaced.

For questions, Contact Flowonix Technical Solutions for assistance at: +1 844-229-6729.

5. Refill The Drug Reservoir

a. Proceed to refill the Drug Reservoir in accordance with the refill procedure defined in

the Refill Kit Instructions for Use.

b. Confirm the correct prescription is programmed, or program a new prescription.

Warning: A period of observation should follow the Refill Procedure to closely monitor

patients for clinical symptoms of underdose or overdose based upon the drug’s

prescribing information.

Page 11 of 13

Pump Model Determination

To identify the pump model prior to an Emergency MRI scan use the following methods:

Inquiry by programmer: Identifies model either as Prometra® or Prometra® II on the

Programmer’s Inquiry Screen. Contact Flowonix Technical Solutions at +1 844-229-6729 if

you require access to a Flowonix Programmer.

Patient ID Card: Identifies the pump model either as Prometra® II (Model # 93827) or Prometra®

(Model # 91827) as noted in the examples on the following page.

o Note: Patients with Prometra® and Prometra® II Pumps also have Medical Alert

bracelets that indicate that the pump must be emptied prior to an MRI.

Contact patient’s pump management physician: The patient’s medical records indicate

the pump model and serial number implanted. Flowonix provides medical chart labels to

facilitate patient record documentation.

Pump serial number: There is a distinct difference in the serial numbers for the Prometra®

Pump versus the Prometra® II Pump. The Prometra® II pump’s serial number ends with an X,

while the Prometra® Pump’s serial number ends with a number.

Contact Flowonix Technical Solutions at +1 844-229-6729: Pump information may be

determined from our patient registration system. This number is staffed 24 hours a day.

Perform an X-ray of the pump: The Prometra® II pump can be differentiated from the

Prometra® Pump via X-rays as shown on the following page. The image of the Prometra® II

Pump shows the addition of the flow-activated valve (FAV) within the Catheter Access

Port.

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Prometra® Pump X-ray Prometra® II Pump X-ray

Catheter Access Port

Flow Activated

Valve

Page 13 of 13

Manufactured by: Flowonix Medical Inc. 500 International Drive, Suite 200 Mount Olive, NJ 07828 USA T +1.973.426.9229 F +1.973.426.0035 www.flowonix.com

PL-71802-00 October 2019

http://www.flowonix.com/

Attachment 2: Patient Guide; PL-81912-03

PATIENT GUIDE For use with Prometra® Programmable Pump System

PATIENT GUIDE Page 2 of 21 For Prometra® Programmable Pump System

Table of Contents Table of Contents ......................................................................................................................... 2

Glossary ........................................................................................................................................ 4

Descriptive Information ............................................................................................................... 5

Potential Benefits of the Prometra Programmable Pump System .......................................... 5

Purpose of the device (approved indications for use) ............................................................. 6

Description of the device ......................................................................................................... 6

Making the Decision if the Pump is Right for You ................................................................... 8

The pump system should not be implanted: Contraindications.......................................... 8

After Your Pump is Implanted: Warnings and Precautions ................................................ 8

Avoid applied electric currents ............................................................................................ 8

Magnetic Resonance Imaging (MRI) and Safety Information .............................................. 8

Avoid transmitting towers, large electrical antennae and in-use welding equipment ....... 9

Do not use radiation therapy in the area of the pump ....................................................... 9

Risks ..................................................................................................................................... 9

Potential Side Effects of Morphine ..................................................................................... 10

Potential Side Effects of Baclofen ...................................................................................... 11

Serious Side Effects of Baclofen ......................................................................................... 12

Benefits .............................................................................................................................. 12

Before, During and After Your Procedure ............................................................................. 12

Your Pump Implant Surgery ............................................................................................... 12

Follow-up Visits .................................................................................................................. 13

Refills .................................................................................................................................. 13

What should I expect after surgery? .................................................................................. 14

Will I need to wear a bandage over the pump? ................................................................. 14

Will others know that I have a pump? ............................................................................... 14

Do I have to wear certain types of clothing? ..................................................................... 14

Can I move my pump, e.g. if it is uncomfortable? ............................................................. 14

How do I know if my pump still works after I bump it or if I fall? What about my catheter? ............................................................................................................................ 14

Will my pump set off metal detectors? Is security “wanding” safe? ................................ 15

What should I do if I hear my pump beeping or making noise? ........................................ 15

Will the use of cell phones, a microwave oven, or other houseshold electrical devices interfere with my pump? ................................................................................................... 15

Do pressure changes affect my pump? .............................................................................. 15

Do temperature changes affect my pump? ....................................................................... 16

Can I travel with my pump? ............................................................................................... 17

What should I do if I move? ............................................................................................... 17

Who do I need to tell about my pump and catheter implant? .......................................... 17

What do I do if I have a question or suspect a problem? .................................................. 18

Clinical Studies ........................................................................................................................... 18

Operating Information ............................................................................................................... 18

Expected failure time and mode ............................................................................................ 18


Instructions on how to safely dispose of the device ............................................................. 19

Additional Information .............................................................................................................. 19

Warranty ................................................................................................................................ 19

Travel or international use ..................................................................................................... 19

Date of Printing .......................................................................................................................... 20

User Assistance Information ...................................................................................................... 20


Glossary Abdomen: soft space between your ribs and hip bones Arachnoid: the middle protective membrane covering the brain and spinal cord Anesthesia: medicine that causes you to lose your ability to sense pain, among other sensations Bolus: large or concentrated dose of medicine Cardioversion: electrical “jump start” for your heart to correct irregular rhythms. Also may be done with medication(s). Catheter: tiny flexible tube CSF: cerebrospinal fluid Chronic: long-term Contrast media: dye that can be seen under x-ray CT: non-invasive, non-magnetic scan used to verify intrathecal catheter position DEHP: Bis(2-ethylhexyl)phthalate, a plasticizer in PVC Defibrillation: stopping the heart from quivering, “fibrillating”, instead of pumping normally. Often done by applying electricity via small paddles but may also be done with medication(s). Dura Mater (Dura): the outermost protective membrane covering the brain and spinal cord Epidural: located outside the dura mater, or anesthesia injected into this space. Explant: to take out; opposite of implant FDA: US Food and Drug Administration Granuloma: Inflammatory mass Hyperbaric: pressures higher than normal atmospheric pressure Implant: to put in Intractable: difficult-to-manage; hard to treat, relieve, or cure Intrathecal space: fluid-filled area around the spinal cord Latex: natural rubber Orally: by mouth Palpable: that which can be felt by touching PVC: polyvinyl chloride, a plastic material Programmable: ability to be controlled remotely Prometra: brand name for Flowonix Medical’s programmable drug delivery pump and pump system Saline: Salt water balanced to match your body’s composition Telemetry: remote transmission of data Vertebra/Vertebral Body: bones or segments which make up the spinal column and through which the spinal cord runs


Descriptive Information Your doctor is recommending this treatment for you because your prior treatments have not been adequate to control your symptoms. This Patient Guide will help you understand your Prometra Programmable Pump System and answer your questions about this treatment. However, it is only a guide and your doctor and nurse are always your best source of information. Be sure to ask them to explain anything that is unclear. And, always follow their directions concerning your Prometra Programmable Pump System.

Potential Benefits of the Prometra Programmable Pump System

Your spinal cord is the main pathway for information connecting your brain and all the rest of the nerves in your body. If you take a pill orally (by mouth), medicine has a much harder time reaching the spinal cord as much of the drug is absorbed by your body along the way. Delivering this dose directly to your spinal cord reduces the amount of medication needed to control your symptoms. For example, published studies show that you can take 1/100th of your medication when it is delivered to your intrathecal space (fluid-filled space around your spinal cord) and achieve the same symptom relief. With a much smaller intrathecal dosage, your side effects may be reduced. Or, your doctor may be able to increase your dosage without as many side effects.


Purpose of the device (approved indications for use)

Your Prometra Programmable Pump System is approved to infuse preservative-free morphine sulfate directly into the intrathecal space to relieve chronic (long-term), intractable (difficult-to-manage) pain or baclofen sterile injection for treatment of severe spasticity. Sterile preservative-free saline (salt water) solution or intrathecal contrast media (dye that can be seen under x-ray) may also be used in your pump. Your doctor may decide to put other medications in your pump other than morphine or baclofen. This is at your doctor’s discretion, as other medications have not been approved for use with the Prometra Programmable Pump System.

Please read the drug label for additional information. The National Library of Medicine at www.nlm.nih.com is a good source for drug information.

Description of the device

The Prometra Programmable Pump System provides drugs directly to your spinal cord. The Prometra pump and its intrathecal catheter are Latex-free, PVC-free and DEHP-free.

http://www.nlm.nih.com/


A tiny intrathecal catheter with holes near the end is carefully placed in your intrathecal space and securely connected to the Prometra programmable pump implanted in your abdomen (the soft space between your ribs and hip bones). Your catheter has a radiopaque tip that can be seen under x-ray.

The pump has a central refill septum that a nurse or doctor can feel underneath your skin (palpate). Your medicine will be refilled every 30-60 days by accessing this refill port with a thin needle. If needed, the nurse or doctor may access your catheter directly to provide a bolus (large or concentrated dose) of medicine through the catheter access septum.

When you initially receive the pump, and at most refills, the nurse or doctor will use a handheld programmer, like a remote control, to set how much medicine to deliver and at what times. Your programmable pump can deliver different amounts of medication at different times of the day, such as more at night while you are sleeping and less during the day.


Making the Decision if the Pump is Right for You

The pump system should not be implanted: Contraindications

When you have an infection, such as a tooth abscess or a bed sore.

If your body type cannot comfortably or safely accommodate the pump size and weight.

If the pump cannot be implanted under your skin 2.5 cm (1 in.) deep.

With spinal column anatomy that would obstruct cerebrospinal fluid flow or prevent intrathecal drug delivery.

If you work or live near high current industrial equipment, transmitting towers, or powerful magnets.

If you need hyperbaric treatments.

If you have allergies to the catheter materials, including silicone rubber, acetal resin, or tungsten.

If you have allergies to the pump materials, including silicone rubber, polyphenylsulfone, buna-n (nitrile) rubber, MP35N metal (multiphase quaternary nimonic alloy primarily composed of chromium, cobalt, molybdenum and nickel), titanium, polyvinylidene fluoride, stainless steel, epoxy resin, acetal resin or tungsten.

If you are deemed an unsuitable candidate after psychological evaluation.

If you are under 22 years old. Safety and effectiveness for use in pediatric patients under 22 years old is unknown.

If you have any contraindication to preservative-free morphine sulfate or baclofen as per the approved drug labeling. The National Library of Medicine at www.nlm.nih.com is a good source for drug information.

EXPOSURE TO MRI ENVIRONMENT WITH PROMETRA PUMP COULD RESULT IN SERIOUS PATIENT INJURY OR DEATH.

After Your Pump is Implanted: Warnings and Precautions

Avoid applied electric currents

Interaction of the Prometra Programmable Pump System with electric currents applied to the body, such as cardioversion or defibrillation, has not been established. In non-emergency situations, the pump should be turned off before application of electric currents. Your doctor will need to confirm that the pump programming has not changed must be carried out as soon as possible after the procedure. Magnetic Resonance Imaging (MRI) and Safety Information

MR Unsafe

http://www.nlm.nih.com/


WARNING: EXPOSURE TO MRI ENVIRONMENT WITH PROMETRA PUMP COULD RESULT IN DRUG OVERDOSE THAT COULD LEAD TO SERIOUS PATIENT INJURY OR DEATH.

Avoid powerful magnets, such as MRI.. Strong magnetic fields, such as those created in Magnetic Resonance Imaging (MRI) devices may cause the valves of the pump to open, resulting in the immediate discharge of the contents of the pump and catheter into your body which could result in a fatal overdose.

Avoid transmitting towers, large electrical antennae and in-use welding equipment

Exposure could result in pump malfunction. Please discuss your local environment and occupation, or potential occupation, with your implanting or pump management doctor.

Do not use radiation therapy in the area of the pump

The effects of ionizing radiation on the Prometra Programmable Pump System have not been established, and these therapies may have effects on pump operation that are not immediately obvious.

Risks

The Prometra Programmable Pump System provides an important means of treating patients with intractable pain and severe spasticity. However, there are potential side effects and complications that you should understand. Also, since your pump and catheter are placed during a surgical procedure, surgical complications may occur. Always discuss the potential risks and benefits of this therapy with your doctor and ask any questions that you have. Lastly, since the Prometra Programmable Pump System may remain implanted for ten (10) or more years, take time to familiarize yourself thoroughly with the therapy and take an active role in your outcome. Potential complications may include:

Accumulation of clear fluid, bleeding, infection, and inflammation near the surgical sites. If you notice redness, swelling or pain at the implant site or have a fever, call your doctor immediately. Infections occur in 5-10% of patients and are typically treated with antibiotics.

Battery depletion or pump failure causing lack of medication delivery. This occurs in 1% of patients and would require pump removal.

Catheter breakage, blockage, disconnection, kinking, and movement. If you notice an increase in symptoms, contact your doctor at once. This occurs in 15% of patients and may require reoperation to reposition or replace the catheter.

Erosion of catheter or pump through the skin. This is extremely rare, and has not occurred with the Prometra pump.

Flipped pump causing inability to perform refills. This occurs mainly as a result of “fiddling” with the pump. This occurs in 1% of patients. This may be able to be re-flipped without surgery or it may require surgery.


Inability to program the device due to programmer failure or loss of telemetry. This occurred in none of our study patients, but it is still possible. If it is permanent, the pump will need to be removed and replaced.

Inflammatory mass (granuloma) or scarring near the catheter. This is uncommon, occurring with similar devices in less than 2% of patients. It usually occurs years after your initial surgery. You need to tell your doctor immediately about any new neurological signs or symptoms, including: Burning, numbness, or tingling Increase in pain despite dose escalation Increased sensitivity to stimuli or pain Progressive change in the type or amount of pain

Pain on injection. If this is different from prior refills, it may be an early sign of infection. Please refer to infection information above.

Programming or refill errors resulting in under-dosing or over-dosing. Errors occur due to miscalculations by medical staff less than 3% of the time.

Rejection of the material in the catheter or pump requiring possible removal of the implants. This is extremely rare, occurring in less than 0.5% of patients.

Reoperation. Reoperation before normal battery failure occurs in 15% of patients mostly due to infection or catheter movement.

Scarring externally or internally at the pump and catheter surgical sites. Everyone has a different tendency to scar more or less, and it varies based on a large number of factors. Your doctor is the best person to ask about this.

Spinal cord injury or pressure or nerve injury causing impaired movement, partial loss of movement, or paralysis. This is an infrequent complication, occurring in 2% of patients. Surgery is typically required to either replace or remove the pump and catheter.

Spinal fluid leak causing headaches or ringing in the ears. This occurs in 7% of patients. The leak may resolve by itself and did so in all of our study patients. If it does not, a reoperation may be required to close the leakage.

Other risks associated with surgery and general or local anesthesia. Your doctor can best advise you about your particular risks based on your individual history.

Reopening of previously closed wound. This occurs in 3% of patients and typically requires reoperation with local anesthesia to repair.

Potential Side Effects of Morphine

If nausea occurs, consult your doctor or pharmacist for ways to decrease it (such as taking antihistamines, lying down for 1 to 2 hours with as little head movement as possible).

This medication may cause dependence, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal reactions (such as restlessness, watery eyes, widened pupils, sweating, runny nose) may occur if you suddenly stop this drug. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.


When this medication is used for a long time, it may not work as well. Your doctor may need to increase your dose or change your medication. Talk with your doctor if this medication stops working well.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Use this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your pain persists or worsens.

Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, increased sweating, or dry mouth may occur. Pain, redness, or swelling at the injection site may occur if this medication is given into a muscle or under the skin. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/shallow breathing, fainting, mental/mood changes (such as agitation, hallucinations, confusion), difficulty urinating, vision changes, slow/fast heartbeat.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, change in the amount of urine, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Potential Side Effects of Baclofen

Careful attention to the programming and monitoring of the pump is required to prevent some of the risks and problems associated with baclofen. To decrease these risks you must go to regular follow-up visits and always follow your study doctor’s instructions. Potential side effects with baclofen include:

The drug not being effective in managing your symptoms

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Sweating, diarrhea, constipation, rash, emotional problems, abnormal thoughts and sudden change in personality, headache, dizziness, seizures, stroke, slow or fast breathing, pneumonia, pulmonary embolus (a blood clot in the lung), sudden decrease or increase in blood pressure, slow or fast heart rate, palpitations, abnormal heart rhythm, urine


retention, kidney failure, increased muscle tone, decreased muscle tone. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Serious Side Effects of Baclofen

Serious Side Effects can occur due to an over-dose, under-dose, or sudden stoppage of baclofen delivery. Seek emergency medical attention immediately if signs of under/overdose appear:

Early symptoms of under-dosing or withdrawal of baclofen can be return to baseline spasticity, itchy skin, low blood pressure, and generalized “pins and needles” in your skin.

Signs of overdosing can be drowsiness, lightheadedness, dizziness, slow or difficult breathing, seizures, and loss of consciousness that could lead to a coma.

Abrupt withdrawal of baclofen may be life-threatening. Signs of a sudden stop of baclofen flow (or “abrupt withdrawal”) into your spine can be: high fever, change in mental status (this might include confusion, amnesia, poor judgment, drastic mood changes), and sudden increase in spasticity. If you do not receive medical treatment, the sudden stop of baclofen flow could result in breakdown of muscle tissue, multiple organ failure, and death.

Benefits

Implantation of the Prometra programmable pump system is usually used when conventional pain treatment is no longer effective. Benefits you can expect include:

Improved symptom relief

Less need for oral medications

Less side effects due to the reduced intrathecal dosage

More functionality and daily activities

Before, During and After Your Procedure

Your Pump Implant Surgery

The Prometra Programmable Pump System will be placed in your body during a surgical procedure that is usually about 1 hour long. You will be given anesthesia which will allow you to sleep through the surgical procedure without pain. Your doctor will give you specific instructions about how to prepare for the surgery. Both the pump and catheter are implanted under your skin. A small incision is made in your back to provide access to your spinal canal. The tip of the catheter is threaded up your spine into your intrathecal space while using a form of x-ray. Your doctor usually places the pump at about waist level (abdomen), above your hip bone and below your ribs, and to one side. The catheter is tunneled underneath your skin from where it enters your spine around your


waist to the pump. The catheter length is then customized to your body and connected to the pump. Your doctor may chose to use sutures near where the catheter enters your spine. This will help the catheter to maintain its position. Your pump will be filled and programmed to deliver your medication at either a constant or variable rate, or it can be set to give a dosage repeated at specified times. Your doctor will determine the best medication schedule for you. When you wake up, you will notice two incisions. Your doctor made one incision in your abdomen to place the pump. Another small incision is made in your back to position the catheter in your spine.

Follow-up Visits

Your first follow-up visit will be scheduled one to two weeks after surgery. At this visit, your doctor will look at the surgical site and review the medication therapy plan that was started when you received your pump.

Refills

Your doctor will schedule regular pump refill visits as needed so that your pump does not run out of medication. This is usually about every 30-60 days. Only your doctor or nurse can program your pump to deliver medication. It is important NOT to miss a refill appointment. You should always let your doctor know as soon as possible if you think you will miss an appointment. This will allow time for a new appointment to be set or for other arrangements to be made. If your pump is not refilled on time, it may become empty, and you will not get your required medicine. When you run out of medicine, your symptoms can range from fairly minor to very serious depending on the medicine you were receiving, such as with baclofen, serious risks can occur due to a sudden stop in drug delivery. Your doctor can describe the symptoms to expect if your pump runs out of medication or if you stop getting medicine from the pump for any reason. To refill your pump, your doctor will insert a special needle of just the right size and length into your pump through the center refill septum. For most patients this causes only a mild pricking sensation. Then, your doctor or nurse will completely empty your pump. Your pump must be emptied to measure the amount of medication that was left in the pump. This allows verification that the pump has been delivering the right amount of medicine to your spinal cord. Your doctor will then refill your pump by attaching a syringe and tubing set filled with your medication to the special needle and pushing the medication into the pump reservoir. Then, your doctor or nurse will program the pump to deliver your medication using the programmer. Once the pump is refilled and programmed by your doctor, the pump will automatically deliver the medication at the programmed dosage rate.


What should I expect after surgery?

After surgery you may have some redness and tenderness in the area where your incision was made. This will normally go away in a few weeks. However, contact your doctor or nurse if you notice unusual changes in the skin area over the pump such as increased swelling, redness, or soreness. For the first few days after you receive the pump, you should avoid heavy exertion and strenuous activities such as lifting or pushing, carrying anything heavy, running, and swimming. Follow all your doctor’s instructions about your pump. Once your incision heals, you should be able to resume normal daily activities such as bathing and exercising.

Will I need to wear a bandage over the pump?

A bandage will be required until your incision heals. After a refill visit, a bandage may be used over the area where the needle was inserted.

Will others know that I have a pump?

After your incision heals, the pump will likely protrude slightly from your abdomen. In thinner people, it tends to protrude more and in larger people, it is less obvious. Your doctor may be able to provide pictures of what the pump looks like in different body types.

Do I have to wear certain types of clothing?

This depends on where your pump is placed. You should avoid clothing that would rub or be tight over the incision site immediately after surgery. Wear loose, comfortable clothing the day of your implant surgery. After the incisions heal, you should be able to wear your normal clothing.

Can I move my pump, e.g. if it is uncomfortable?

Your pump has been placed with the refill septum facing up so it can communicate with the programmer in your doctor’s office. Never move, twist or turn your pump. This may flip your pump or cause damage to the catheter. Either of these may interfere with delivery of your medication or require reoperation. However, typical movement should not result in damage to the catheter or pump.

How do I know if my pump still works after I bump it or if I fall? What about my catheter?

A slight bump is unlikely to affect your pump or catheter. However, if you hurt yourself when you fell, you may have hurt the pump or catheter. If you experience a significant increase in symptoms or notice unusual symptoms, contact your doctor immediately. To verify if your pump and catheter are working, your doctor or nurse will check the amount of medication left in the pump. If too much is left, they may perform an x-ray or CT to verify proper catheter and pump position.


Will my pump set off metal detectors? Is security “wanding” safe?

It may. And, as some personnel are not familiar with the implant card with which you will be provided, you may be asked to show them the pump site. Please consider this when dressing for court appointments, air flights and other facilities where metal detectors might be encountered. If you need to be “wanded” by security personnel, e.g. at the airport, the pump programming will not be affected.

What should I do if I hear my pump beeping or making noise?

Your Prometra programmable pump has two alarms. Both alarms use the same beeping tone but have a different beep length and different number of beeps in a group. Contact your doctor immediately if you hear these alarms. The Low Reservoir Alarm warns you when the medication in the pump reservoir gets below a certain volume. Your doctor can set this volume, and the alarm can be turned on using the programmer. If the alarm is on and the reservoir volume gets low, the pump sounds two short beeps every 30 minutes. The alarm continues to sound until your doctor turns it off using the programmer or refills your pump. The Critical Error Alarm indicates that the pump has stopped delivering medication. The pump sounds three long beeps every 30 minutes. This alarm occurs any time the pump is not delivering medication, including a low pump battery. Once the Critical Error Alarm has occurred, the pump stops pumping medication. Your doctor cannot turn off the alarm with the programmer. Your pump will keep beeping until it is replaced or until the battery runs completely out of power. There is no way to replace the battery only. The pump must be disconnected from the catheter and replaced. A new pump can be implanted and connected to the original catheter. Contact your doctor as soon as possible to schedule pump replacement surgery or to assess therapy alternatives.

Will the use of cell phones, a microwave oven, or other houseshold electrical devices interfere with my pump?

No. Your pump is designed so that cell phones, microwaves, or other household appliances and items that you may use in your normal daily life will not affect it. If you suspect interference with your pump, move away from or turn off the electrical device. Your pump will not be permanently affected.

Do pressure changes affect my pump?

The Prometra programmable pump has a special design which isolates the drug reservoir from most pressure changes, making it immune to most pressure changes. You are free to enjoy, with your doctor’s permission:

Flying

Mountain hikes up to 10,000 feet

Skiing up to 10,000 feet


Snorkeling within 15 feet of the surface

Swimming within 15 feet of the surface These activities are SAFE and WILL NOT AFFECT YOUR PUMP. Always consult your doctor first about any other activities not listed here.

Activities such as scuba diving or hyperbaric therapy may cause the pump to temporarily stop delivering drug. When you return to normal atmospheric pressure, your pump will resume its programmed drug delivery. Discuss these activities with your doctor to see if you can safely be without your drug during scuba diving or hyperbaric therapy.

Do temperature changes affect my pump?

The Prometra programmable pump has a special design which isolates the drug reservoir from most temperature changes, making it immune to most temperature changes. You are free to enjoy, with your doctor’s permission:

Hot tubs

Whirlpool baths

Saunas These activities are SAFE and WILL NOT AFFECT YOUR PUMP. Always consult your doctor first about any other therapies not listed here.


Even temperature-related therapies such as deep heat therapy, e.g. diathermy, will not affect the operation of the pump. Always consult your doctor first about any other activities not listed here.

Can I travel with my pump?

The Prometra programmable pump provides you with the freedom to travel. Let your doctor know if you plan to travel so that pump refill arrangements can be made, if necessary. Also, your doctor can advise you of a doctor in the area you are traveling to in case you have any problems.

What should I do if I move?

Contact your doctor to ask for help finding a new pump management physician who can perform your refills. Then, when you have your new address, please contact Customer Care at +1 844-229-6729 so we can update our database in case we need to contact you.

Who do I need to tell about my pump and catheter implant?

You need to tell all medical personnel about your implant. This includes doctors, nurses and medical technicians, such as MRI or X-ray technicians. Knowing about the implant may change their treatment or how they conduct or interpret a medical test. To make this easy for you, you will receive an implant card and medical bracelet that contains important information about your Prometra programmable pump and intrathecal catheter. Your implant card and medical bracelet should be carried with you at all times.


What do I do if I have a question or suspect a problem?

If it is an emergency, always call 112. If you have pain, fever, chills, shortness of breath, dizziness, or other side effects, contact your doctor immediately. Also, if your pain or spasticity increases or worsens, contact your doctor immediately. If you have any questions or suspect a problem, please contact your implanting or pump management doctor immediately.

Clinical Studies

In the first clinical study, 110 patients were implanted. Clinical data has been collected on the majority of patients over 12 months. Overall, accuracy of dose delivery was 97%, which is highly accurate. Patients achieved a reduction in pain which was sustained over 12 months. Past the initial 10 days post-implant when medication is being adjusted, there were no reported overdoses, underdoses or withdrawal symptoms noted.

Operating Information

Expected failure time and mode

The Prometra programmable pump has a battery which powers the pump. The normal battery life of the pump is 10 years at a drug delivery rate of 0.25 mL/day. If you receive a higher flow rate, your battery life may be less. If you receive a lower flow rate, your pump battery should last longer. The chart below will give you an idea of your pump life. If you have any questions, please ask your implanting or pump management doctor.


The only way you can monitor the activity of your Prometra programmable pump system is by keeping track of how well your symptoms are controlled. Please keep a diary or other daily record of your levels, noting your activities immediately preceding an increase or decrease in symptoms. Set aside time to regularly discuss your symptom record with your doctor or refill nurse. Taking an active role in your care will help you to achieve the best symptom control.

Instructions on how to safely dispose of the device

The pump can be removed by your doctor in a surgical procedure like the one that was used to put the pump into your body. Once your pump is explanted, it will be returned to Flowonix Medical for proper disposal. The pump will need to be explanted upon your death. If you are terminally ill, please notify your caregiver and primary doctor that the pump will explode during cremation and needs to be removed prior to cremation or burial.

Additional Information

Warranty

Flowonix Medical, Inc. (“Flowonix”) warrants to the first purchaser of this product that this product will be free from defects in materials and workmanship for a period of one year from the date of first purchase, and liability under this limited product warranty will be limited to repairing or replacing the defective product, at Flowonix’s sole discretion, or refunding the net price paid. Wear and tear from normal use or defects resulting from misuse of this product are not covered by this limited warranty. TO THE EXTENT ALLOWABLE BY APPLICABLE LAW, THIS LIMITED PRODUCT WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT WILL FLOWONIX BE LIABLE TO YOU FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM YOUR HANDLING OR USE OF THIS PRODUCT. Some states/countries do not allow an exclusion of implied warranties, or incidental or consequential damages. You may be entitled to additional remedies under the laws of your state/country.

Travel or international use

There are no restrictions on travel. However, you will want to arrange with your doctor in advance to obtain the name of a local pump management doctor in case of emergency or prolonged vacation requiring a refill.


Date of Printing Contact Flowonix Medical for a new patient guide when this guide is two years from date listed on last page of this document.

User Assistance Information Please contact us with any questions or comments either via phone, email or the web. We always welcome patient input.

[email protected]

flowonix.com If you wish to write to us, we would love to hear from you. Here is our address:

Flowonix Medical Inc. 500 International Drive, Suite 200 Mount Olive, NJ 07828 USA T 973.426.9229 F 973.426.0035


Trademarks are the property of their respective owners. US and Foreign patents issued and pending. Please consult flowonix.com for the most up-to-date information.

Rx only

© Flowonix Medical Inc. 2019. All rights reserved. Manufactured by: Flowonix Medical Inc. 500 International Drive, Suite 200 Mount Olive, NJ 07828 USA T +1.973.426.9229 F +1.973.426.0035 flowonix.com

PL-81912-03 October 2019

Attachment 3: Prometra (l) Temporary Patient ID Card; PL-82375-04

Attachment 4: Physician - Field Safety Notice Response Form; PL-71205-00

PL-71205-00

Physician:

Hospital:

Address:

City:

Country:

Acknowledgement:

I have received, read, and understand the Physician Flowonix Urgent Field Safety Notice (FSN2019-044-02) regarding the latest EU MRI scanning instructions associated with the Prometra Pump Systems. I will forward this Field Safety Notice information to staff, associated MRI centers, patients and all those who need to be aware of the latest MRI scanning instructions associated with the Prometra Pump Systems within my organization.

Signature:

Printed Name:

Title:

Date:

EMAIL TO: [email protected]

PHYICIAN - URGENT FIELD SAFETY NOTICE RESPONSE FORM CC FSN2019-044

Prometra® Programmable Infusion Systems

mailto:[email protected]

Documents

URGENT FIELD SAFETY NOTICE - Flowonix