A report Tuesday from Kaiser Health News has put Medtronic on the defensive.
The report stated the Minneapolis-based health tech manufacturing company made a deal with the U.S. Food and Drug Administration (FDA) to hide information about malfunction incidents of Medtronic’s Sprint Fidelis device. The Kaiser Health News report said Medtronic and the FDA worked to “keep reports about the widely used device’s malfunction incidents–now totaling 50,000—shielded from public scrutiny.”
In a response released Wednesday, Medtronic spokesman Rob Clark said: “the statement, and therefore, the entire premise of the story is not true.”
Kaiser Health News’ story referred to the 2007 recall of Sprint Fidelis, a defibrillator implanted into the chests of patients with abnormal heartbeats to shock the heart back into rhythm if needed.
The recall was issued after the device had already been implanted into hundreds of thousands of patients. The company issued the recall due to reports of the Sprint Fidelis giving patients random electrical jolts and also failing to work in actual cardiac emergencies, according to a Medtronic letter to doctors in October 2007.
Allegedly, after the recall, the FDA allowed Medtronic to keep the now 50,000 total incidents quiet through an “alternative summary reporting” program.
FDA spokeswoman Deborah Kotz told Kaiser Health News that the program involved a reporting exemption given if “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.” But Kotz added the program was essentially shut down in 2015.
Medtronic acknowledged it received the summary report exemption but said it was about efficiency, not about keeping information from the public.
“Simply put, the company could have provided 50,000 individual adverse event reports into the MAUDE (Manufacturer and User Facility Device Experience) database which all said the same thing or Medtronic could merely report in summary reporting fashion the 50,000 malfunctions,” said Clark.
Medtronic’s statement also noted that the Sprint Fidelis incidents were reported to the community, patients, and public alike.
“The Sprint Fidelis lead has been the most scrutinized, studied and reported on defibrillator lead in the history of our industry,” said Clark.
Furthermore, the company asserted it provides all its lead product performance reports to the public, with updates every six months and detailed descriptions of device reliability. In addition, the 50,000 Sprint Fidelis incidents have been reported as part of the ongoing performance monitoring of that particular device, according to Medtronic.
“To suggest the FDA and Medtronic somehow conspired to hide data on this product is completely untrue and unsubstantiated,” added Clark.
In an email to Kaiser Health News, Kotz supported this notion, noting Medtronic and the FDA have been working together to monitor device performance and guide patient management to address the issue.