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Hidden reports masked the scope of widespread harm from faulty heart device

Christina Jewett, Kaiser Health News on

Published in News & Features

Faced with the possibility that a bout of abnormal heartbeats could end his life, in 2006, Dr. Marc Sicklick had a small device implanted in his chest that would shock it back into rhythm. Soon he would struggle with another life-or-death choice: whether to remove the Sprint Fidelis, which was deemed dangerous and recalled in 2007 after it had been implanted in hundreds of thousands of patients.

The Sprint Fidelis was prone to giving patients random electrical jolts -- and sometimes failed to fire in genuine cardiac emergencies, according to manufacturer Medtronic's letter to doctors.

What Sicklick and thousands of others in his position have not known is that the Food and Drug Administration quietly took steps to keep critical information out of the public light. Shortly after the recall, the FDA and Medtronic made a deal to keep reports about the widely used device's malfunction incidents -- now totaling 50,000 -- shielded from public scrutiny.

The FDA has allowed device makers to file 1.1 million reports of injuries or malfunctions to a little-known internal FDA database since 2016, a recent Kaiser Health News investigation has found, spurring top FDA officials to pledge to open those records within weeks and shut down the "alternative summary reporting" program.

For the past two decades, the agency has granted various devices different types of so-called exemptions from reporting to their public-facing database, called MAUDE, KHN has found.

One of those exemptions covered the Sprint Fidelis. In May 2008, it was granted a "remedial action" exemption -- allowed when "the manufacturer has initiated reasonable and appropriate actions to mitigate the problem(s)" and further reports of harm will not "provide any significant new data," FDA spokeswoman Deborah Kotz said in an email. She said the FDA hasn't granted such an exemption since 2015 and has "effectively ended the program," and could not say whether that data would be opened to the public soon.

 

The logic of the FDA's approach sits poorly with patients like Sicklick who have a Sprint Fidelis buried deep in their chests. "Worrying about it not working (has) caused a tremendous, tremendous amount of anxiety in me, and I'm not an anxious person," said Sicklick, an allergy specialist from Long Island, N.Y. "I think the FDA should be making this information public."

Six top cardiologists interviewed for this report said they weren't aware the FDA had granted Medtronic such an exemption.

"Amazing. Really amazing," said Dr. Robert Hauser, the Minnesota cardiologist whose research first brought the high rate of Sprint Fidelis failures to light. "It's not in the best interest of the patients who have these devices."

Hauser and other doctors have spent years helping patients navigate the risks of living with a cardiac implant that could harm them or undergoing a complicated device-removal surgery that could prove deadly.

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