STEPHEN M. DOLLE
FDA & Patient Advocate
3908 ½ River Avenue
Newport Beach, CA 92663
July 11, 2002
David Feigal, Ph.D.
Director
Center for Devices and Radiological Health
HFZ-1, 9200 Corporate Blvd.
Rockville, MD 20850
Re: Request to Place CNS Shunts on List for New
Postmarket 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 the
FDAMA, 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 of
performance and outcomes assessment measurement. Central nervous system shunts
are well known to pose an unusually high risk of product failure, often involving
indeterminent and poorly understood outcomes. Currently, there is no standard or
widely accepted means of ascertaining proper function and performance, and this
burden is unfairly passed on to user physicians and patients. More detailed user
information, documentation, and literature must be made available to user physicians,
with specific user information made available to user patients for their safe and
effective use.
This request is based upon current problem device data known to the CDRH, the
Multi-Center CNS Shunt Study results reported by Kestle, et. al. (1999), conclusions
found by the 1999 STAMP Conference on CNS Shunts, data summarized in my Petition
to 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) Failure
could be reasonably likely to have serious adverse health consequences.

David Feigal, Ph.D.
July 11, 2002
Page Two
CNS shunts may benefit from this new and additional PS, in that it may “identify
actions that minimize risks, such as training, labeling, design modification, or patient selection
criteria. In extreme cases, surveillance may show that the subject device be removed from the
market.”
According to the rule, the CDRH may require this new PS without consulting
with shunt manufacturers. However, I would be agreeable if you held an industry
meeting. 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 CNS
Shunts in 1999, I would have thought such reforms in performance measurements and
outcomes 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 mark
requiring that I have a shunt to live. I was never given any user information on any of
the CNS shunts implanted in me, nor do I believe my neurosurgeons sufficiently
understood the shunts used in my care. I was also rendered “disabled” by hidden
problems with my Delta shunt. Today, we have no true data on hydrocephalus and
disability. I attribute such failures to “labeling, literature, study formats, and
postmarket surveillance.”
The poor performance status of CNS shunts, well known to the CDRH, forced
me to design a shunt assessment model in 1997, named the DiaCeph Test, to provide test
documentation for my corrective surgery in 1998. I regret to say today very little has
changed in the way of outcomes and warnings information as was mandated by the
CDRH in their ruling on the above Petition on these shunts. The CDRH and myself
have been made to be a “fool” by such failures. My shunt outcomes assessment model
sits on a shelf while patients face daily uncertainty and disability because the CDRH
won’t pass much needed mandates and reforms, nor will any shunt manufacturer take
the 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 toward
new PS, and implement any other new reforms that it deems are necessary.
Truly,
Stephen M. Dolle
Hydrocephalus Patient & Advocate
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