FDA Acknowledges Medical Device Underreported Malfunctions

WASHINGTON, D.C. — The United States Food and Drug Administration acknowledged that problems with medical devices are underreported. This is a dangerous situation, which, according to some, the FDA is making worse. Kaiser Health News said that many reports, including those filed regarding the Sprint Fidelis defibrillator manufactured by Medtronic, are intentionally hidden from public view under an exemption to the FDA’s reporting requirements. The practice endangers patients and prioritizes sales over patient safety and corporate integrity. The FDA vowed to alter this practice and make previously hidden reports public.

The FDA rules regarding public reporting of adverse health consequences suffered by patients implanted with medical devices are simple: every complaint that a medical device manufacturer receives regarding one of its devices must be reported to the FDA and input into a publicly accessible system called MAUDE, that is, unless the company can claim an exemption from the reporting requirement. Medtronic claimed exemption from MAUDE reporting requirements when the company received complaints about the failures of its Sprint Fidelis defibrillator system.

In 2007, the FDA recalled the Sprint Fidelis defibrillator system. The FDA learned that the defibrillator’s leads would cause the wearer to suffer seemingly random shocks. However, the Sprint Fidelis proved to be unreliable in an emergency as well. The defibrillator would not fire in genuine medical emergencies as designed to restart the patient’s heart or shock it back into normal sinus rhythm.

The FDA exempted Medtronic from the MAUDE reporting requirements. The FDA allowed Medtronic to claim a remedial action exemption. The FDA’s remedial action exemption permitted Medtronic to hide the failings and dangers of the Sprint Fidelis from public view because, in the FDA’s estimation, Medtronic instituted appropriate corrective action and taken steps to solve the problems. Furthermore, the FDA rationalized that additional reporting would not add new data to the database. As a result, the FDA gave Medtronic permission to follow the agency’s alternative summary reporting procedure which shielded the information from public scrutiny.

The FDA says the alternative reporting procedure option is no longer available and will make the reports public via MAUDE.

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