According to a story broken by Kaiser Health News this week, due to a reporting waiver granted to Medtronic by the FDA, as many as 50,000 problems with the Medtronic Fidelis lead were not reported to the FDA. Ordinarily, the FDA uses its MAUDE database to collect reports of adverse events in medical devices. In these cases, the MAUDE database was circumvented.
Medtronic responded by saying that instead of using MAUDE, they disclosed the issues in summary fashion to the FDA, as well as reporting them to physicians and to the public.
The following stories provide additional details about this controversy:
HCM Beat 
This story frightens me about the FDA / CDRH. I’d love to hear the FDA’s rationale to grant Medtronic a waiver in reporting device problems. Physicians and patients need to be informed about device failures in order to determine a patient’s risk that the device will fire inappropriately or fail to deliver therapy when needed. The longer devices and especially leads remain implanted, the harder they are to extract.
What other devices have been granted reporting waivers??? Do we need a Sunshine Act for the FDA?
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