When Medtronic medical device manufacturer withdrew its market from the popular but fracture-prone Sprint Fidelis market defibrillator a decade ago, a cascade of complaints involving tens of thousands of lean-wire devices quickly followed .

The derivations, which allow an implanted defibrillator to shock the heart and prevent a sudden death, have been the subject of more than 36,900 reports of problems, ranging from the delivery of unnecessary shocks (2,898 reports) to fractures wires (22 093). But these reports were not known to the public until this week.

The public now has a clearer view of the risk profile that Medtronic has developed regarding its problem-prone devices, following a report released Monday by Kaiser Health News that revealed the wealth of nearly 37,000 undisclosed patient complaints in the Food and Drug Administration's public database. device problems, MAUDE.

Although the Minnesota-based Med-tech medical equipment manufacturer removed the devices from the hospital warehouses, it did not recommend that they be removed surgically from the vaults, as the risk of removal seemed to outweigh the risks of leaving the devices in place. .

On Tuesday, Medtronic spokesman Jeffrey Trauring said the company has been issuing regular reports to the medical community since 2007, revealing the latest failure rates for probes, based on reports from the medical community. adverse events, device registry data and independent studies. A spokesman for the FDA issued a similar comment on Tuesday, noting that Medtronic's product performance reports have been published twice a year for more than 15 years.

The issue is the use of an obscure but controversial flaw in federal law. It states that, although device manufacturers must report device malfunctions and serious injury and death situations to the FDA's public database MAUDE, the agency has the power to To grant confidentiality to the device manufacturers the possibility to classify summaries of undesirable events in secret.

This was done when the reports were deemed redundant because the issues were well-defined, although critics say that companies specializing in computing devices could also have financial incentives to file such reports in private.

Abstracts are technically still public information, available via a process of several months under the Freedom of Information Act, but only when someone learns that a resume exists. Information on summary reports has long been removed from the MAUDE public reports, although the 2016 Star Tribune convinced the FDA not to write documents containing hundreds of thousands of events, including more than 1,000 Post-surgical problems until then unknown involving experimental applications of Medtronic's infuse. bone growth product.

Subsequent investigations showed that Medtronic was one of the most prolific users of the reporting system, with more than 46 individual abstracts approved between 2007 and 2015, covering some 6,399 events. But even that did not reveal the summary of 36,900 individual reports describing more than 50,000 problems associated with Sprint Fidelis leads.

In March, Dr. Scott Gottlieb, then commissioner of the FDA, announced that the agency would make available to the public the old summary reports. (Gottlieb resigned in May.) FDA officials said the agency was planning to completely eliminate the program called "Alternative Synthesis Report" later this year, though it was not not clear if other forms of synthesis report will continue.

Medtronic stated that individual adverse event reports such as the 36,900 reports on Sprint Fidelis are not as meaningful as the information for physicians contained in its product performance reports. The last report of this type has 204 pages and contains four pages summarizing the number of Sprint Fidelis leads sold, the number remaining in the field and the number of companies sent back to the company for the analysis of products dealing with types of failures. such as wire fractures.

Approximately 74 percent of the 186,698 drivers in the US registered 6949 Sprint Fidelis remained in service for 10 and a half years after Medtronic voluntarily pulled them off the market, the report said.

The report does not contain any narrative information about patients or injuries, nor details such as how the devices were programmed by the doctor, whether the patient had any other health problems or if the patient died.

"Manufacturers are encouraged to write summary reports because they are not obliged to provide so much information.The information they provide is not made public," said the former head of the company. the FDA, Madris Tomes, who now runs a service called Device Events. reviews reports of adverse events from the FDA.

Filing a narrative adverse event report in MAUDE does not mean that anyone who has legally determined that a device has directly led to the reported problem.

Between 2004 and 2007, Medtronic sent more than 260,000 Sprint Fidelis leads to one of the device's main selling points, its thin profile, significant because a lead rests in a blood vessel leading to the heart. and it's not a simple thread. A defibrillator driver transmits physiological data from the heart to the device and then sends electricity back to the heart, depending on whether the readings indicate that the heart needs light pulses for making pacemarts or severe shocks for defibrillation .

In March 2007, Medtronic reported receiving reports of fractures in thin conductors, which could prevent the defibrillator from providing treatment or unnecessary shocks. Studies have estimated that the recall cost Medicare more than $ 287 million.

On Tuesday, Trauring rejected the idea that information on problems with Sprint Fidelis runs had been hidden from the public.

"Sprint Fidelis' advance has been most thoroughly examined, studied and reported in the history of our industry. To suggest that the FDA and Medtronic conspired to hide data on this product … is totally false and unfounded, "writes Trauring. "When malfunctions occur, we strive to inform regulators, the health sector and the public in a timely, transparent and compliant manner, and we are confident that we have done so and continue to do so. to do it with Sprint Fidelis. "