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FDA to End Alternate Summary Reporting Program

WASHINGTON D.C. — An article from CNN revealed that Medtronic’s Sprint Fidelis cardiac pacemaker and tens of thousands of other devices are exempt from public scrutiny because the FDA would permit medical device manufacturers to file summary reports of malfunctions rather than file full reports that would be made public by the agency. This process of allowing […]

FDA to End Alternate Summary Reporting Program

Cardiac pacemaker

WASHINGTON D.C. — An article from CNN revealed that Medtronic’s Sprint Fidelis cardiac pacemaker and tens of thousands of other devices are exempt from public scrutiny because the FDA would permit medical device manufacturers to file summary reports of malfunctions rather than file full reports that would be made public by the agency. This process of allowing summary reporting of adverse events was how Medtronic could hide 50,000 adverse complaints about its Sprint Fidelis pacemaker since 2007. CNN reported that Medtronic reached an agreement with the FDA to keep the malfunction reported by patients wearing the defective pacemaker from the public eye.

According to CNN’s report, 1.1 million medical device manufacturers and distributors have utilized the FDA’s alternative summary reporting scheme to inform the FDA that there was a problem with their device. The FDA’s public database is known as MAUDE, and FDA regulations require physicians and others to input adverse events into the database unless the medical device manufacturer or another interested party can find an exemption from the rule.

In the case of Medtronic’s Sprint Fidelis, the FDA agreed in 2008 that the FDA’s remedial action exemption applied. This exemption from reporting may be used when the FDA determines that the company already took significant steps to remediate the problem and that reporting will not generate any additional useful data. The remedial action exemption allowed Medtronic to hide behind a loophole when patients were wondering whether the device implanted in their chests designed to intervene if the patient went into cardiac arrest would work when needed.

An FDA spokesperson told CNN that the remedial action exemption has not been invoked by the agency since 2015 and has essentially been phased out. Notwithstanding, the spokesperson did not provide any information that would shed light on when all of the alternative summary reports would be made public.


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