WASHINGTON, D.C. — A renown physician notice he had an irregular heartbeat and in 2006, he had a Sprint Fidelis defibrillator made by Medtronic implanted into his chest. The device was designed to shock the heart back into its correct rhythm if it skipped a beat. However, the device did not work as advertised. Instead, the device sent random shocks into the doctor’s heart and, according to the letter distributed to physicians authored by Medtronic, would not work in medical emergencies as designed according to KHN. The doctor faced a terrible choice. He could try to live with the defective device or face complicated and dangerous removal surgery after the FDA recalled the product in 2007. The doctor and over one hundred thousand patients like him needed to that difficult choice. The FDA and Medtronic conspired to compound the problem when the FDA agreed to allow Medtronic to keep complaints out of the public eye.
The deal the FDA and Medtronic struck allowed Medtronic to keep patients in the dark and conceal 50,000 reports of malfunctioning Sprint Fidelis devices. Medtronic was not the only company who benefitted from the FDA’s lax reporting standards. Since 2016, the FDA allowed 1.1 million reports filed by medical device manufacturers discussing malfunctions and injuries caused by their products to a database maintained internally by the FDA. By contrast, the FDA also runs a public database called MAUDE. Physicians and patients can report adverse incidents to the FDA via MAUDE.
FDA regulations obligate medical device manufacturers to report adverse incidents to it. The FDA will make the reports public unless the agency exempts the reporting company from its reporting requirements. The FDA agreed to exempt Medtronic from its reporting requirements in 2008. As a result, about 50,000 complaints about the Sprint Fidelis defibrillator remained from the public’s watchful eye.
The FDA said it would end the practice and make those reports public as soon as possible.
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