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:
Minneapolis Star Tribune
The U.S. Food and Drug Administration today issued a safety advisory regarding St. Jude Medical implantable cardiac devices used in conjunction with St. Jude’s proprietary Merlin @home Transmitter.
According to the advisory, these devices could potentially be vulnerable to hacking. However, only a highly skilled hacker would be sophisticated enough to exploit the vulnerability. Such unwarranted interference could conceivably cause premature battery depletion or unnecessary shocks.
A software patch has been developed for the Merlin @home monitor designed to address the issue and to reduce the risk of hacking. The update is now available and will be applied automatically to the Merlin monitor.
***Patients only need to make sure their Merlin@home Transmitter remains plugged in and connected in order to receive the software patch.***
Short-selling firm Muddy Waters first went public with this information in August, believing that it might cause a pending $25 billion acquisition of St. Jude Medical by Abbott Laboratories to fall apart. However, the deal closed last week despite the issue.
This article on Medscape
This article in the Minneapolis Star Tribune.
This article on Huffington Post.
This article on CNBC.