When medical device maker Medtronic pulled its popular but fracture-prone Sprint Fidelis defibrillator leads from the market a decade ago, a cascade of complaints involving tens of thousands of the skinny wire devices soon followed.
The leads, which allow an implanted defibrillator to shock the heart and prevent sudden cardiac death, were the subject of more than 36,900 individual reports of problems, ranging from delivery of unneeded shocks (2,898 reports) to fractures in the wires (22,093). But those reports were not known to the public, until this week.
The public is getting a clearer view of the risk profile that Medtronic developed regarding its problem-plagued devices, following a report Monday by Kaiser Health News that uncovered the trove of nearly 37,000 previously undisclosed patient complaints in the Food and Drug Administration's public-facing database of device problems, MAUDE.
Although the Minnesota-based med-tech manufacturer pulled the devices from hospital stockrooms, it didn't recommend surgically removing the devices from people's chests because the risks from removal appeared to outweigh the risks of a leaving the devices in place.
On Tuesday, Medtronic spokesman Jeffrey Trauring said the company has issued regular reports to the medical community since 2007 disclosing the latest failure rates for the leads, based on adverse event reports, device registry data and independent studies. An FDA spokeswoman issued a similar comment Tuesday, noting that Medtronic's "Product Performance Reports" have been published twice a years for more than 15 years.
At issue is the use of an obscure but controversial loophole in federal law. It says that although device makers must report device malfunctions and situations of serious patient harm and death to the FDA's public MAUDE database, the agency has the power to confidentially grant device companies the ability to file summaries of adverse event reports in secret.
This has been done when the reports were judged redundant because the problems were well-characterized, though critics say device companies might also have financial incentives to file such reports in private.
The summaries are technically still public information, available through a monthslong Freedom of Information Act process, but only when someone learns a summary exists. Information on summary reports has long been redacted from public MAUDE reports, though the Star Tribune in 2016 convinced the FDA to un-redact filings covering hundreds of thousands of events, including more than 1,000 previously unknown post-surgical problems involving experimental applications of Medtronic's Infuse bone-growth product.
Subsequent investigations showed Medtronic was one of the most prolific users of the summary-reporting system, with more than 46 individual summaries approved between 2007 and 2015, covering some 6,399 events. But even that deep dive into the FDA's filings did not reveal the summary of 36,900 individual reports describing more than 50,000 problems associated with Sprint Fidelis leads.
In March, then-FDA Commissioner Dr. Scott Gottlieb announced that the agency would make old summary reports available to the public. (Gottlieb stepped down in May.) FDA have said the agency plans to fully phase out the program called "alternative summary reporting" later this year, though it's not clear whether other forms of summary reporting will continue.