STEPHEN M. DOLLEFDA & Patient Advocate3908 ½ River AvenueNewport Beach, CA 92663

July 11, 2002

David Feigal, Ph.D.DirectorCenter for Devices and Radiological HealthHFZ-1, 9200 Corporate Blvd.Rockville, MD 20850

Re: Request to Place CNS Shunts on List for NewPostmarket Surveillance, Docket No. 00N-1367

Dear Dr. Feigal:

It has come to my attention the Center for Devices and Radiological Health(CDRH) has undertaken new “Postmarket Surveillance” (PS), under Section 522 of theFDAMA, for medical devices posing frequent and dangerous product failures.

I am requesting that “CNS shunts” be added to this PS list, or at the very least,you hold a special meeting with industry to establish new PS mechanisms ofperformance and outcomes assessment measurement. Central nervous system shuntsare well known to pose an unusually high risk of product failure, often involvingindeterminent and poorly understood outcomes. Currently, there is no standard orwidely accepted means of ascertaining proper function and performance, and thisburden is unfairly passed on to user physicians and patients. More detailed userinformation, documentation, and literature must be made available to user physicians,with specific user information made available to user patients for their safe andeffective use.

This request is based upon current problem device data known to the CDRH, theMulti-Center CNS Shunt Study results reported by Kestle, et. al. (1999), conclusionsfound by the 1999 STAMP Conference on CNS Shunts, data summarized in my Petitionto FDA No. 96P-0444, and continued “shunting outcomes” concerns and adverse data.

CNS shunts meet ALL of the criteria necessary under FDA risk assessment/and baseline conditions for this new PS in that they:

(1) Are intended to be implanted in the human body for more than 1 year; (2) Are life-sustaining or life-supporting and used outside a device user facility; and (3) Failurecould be reasonably likely to have serious adverse health consequences.

David Feigal, Ph.D.July 11, 2002Page Two

CNS shunts may benefit from this new and additional PS, in that it may “identifyactions that minimize risks, such as training, labeling, design modification, or patient selectioncriteria. In extreme cases, surveillance may show that the subject device be removed from themarket.”

According to the rule, the CDRH may require this new PS without consultingwith shunt manufacturers. However, I would be agreeable if you held an industrymeeting. This request comes a bit deja vu, in that after writing my shunt Petition No.96P-0444 in 1996, and after having the CDRH hold the STAMP Conference on CNSShunts in 1999, I would have thought such reforms in performance measurements andoutcomes assessment would have been implemented. But this has not been the case.

I am a patient user of a CNS shunt, and recently passed my 10-year markrequiring that I have a shunt to live. I was never given any user information on any ofthe CNS shunts implanted in me, nor do I believe my neurosurgeons sufficientlyunderstood the shunts used in my care. I was also rendered “disabled” by hiddenproblems with my Delta shunt. Today, we have no true data on hydrocephalus anddisability. I attribute such failures to “labeling, literature, study formats, andpostmarket surveillance.”

The poor performance status of CNS shunts, well known to the CDRH, forcedme to design a shunt assessment model in 1997, named the DiaCeph Test, to provide testdocumentation for my corrective surgery in 1998. I regret to say today very little haschanged in the way of outcomes and warnings information as was mandated by theCDRH in their ruling on the above Petition on these shunts. The CDRH and myselfhave been made to be a “fool” by such failures. My shunt outcomes assessment modelsits on a shelf while patients face daily uncertainty and disability because the CDRHwon’t pass much needed mandates and reforms, nor will any shunt manufacturer takethe necessary initiatives. It is plausible that CNS shunts could become a Class III device.

I respectfully request that the CDRH take the necessary immediate steps towardnew PS, and implement any other new reforms that it deems are necessary.

Truly,

Stephen M. DolleHydrocephalus Patient & Advocate

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