FDA Releases Millions of Records of Incidents Involving Medical Devices

Joe Carlson and Jim Spencer, Star Tribune; June 21, 2019

The U.S. Food and Drug Administration on Friday published millions of previously undisclosed reports of problems and post-surgical complications involving medical devices, including reports on implantable cardiac defibrillators, pacemaker electrodes and dental implants.

The roughly 6 million reports released Friday cover a wide array of devices in reports that were secretly filed with the FDA from 1999 to April of this year. From Allergan to Zimmer, dozens of medical device makers have filed reports on everything from breast implants and heart monitors to pediatric breathing machines. Device makers with Minnesota ties in the data include Boston Scientific, Coloplast, Medtronic and the former St. Jude Medical.

Advocates for public transparency cheered Friday’s announcement. The industry’s biggest trade group, AdvaMed, said it supported the move.

Medical device companies are required by law to file such reports within 30 days of learning that a device may have caused a patient injury or death, though the law contained a loophole that allowed millions of files to remain hidden as “summaries.” The FDA said many of these summary reporting arrangements were allowed because new files were duplicative and wouldn’t add to the body of knowledge about existing problems in Manufacturer and User Facility Device Experience (MAUDE), the FDA’s public database of adverse event reports.

The Alternative Summary Reporting (ASR) program “allowed the FDA to more efficiently review reports of well-known, well-understood adverse events, so we could focus on identifying and taking action on new safety signals and less understood risks,” the FDA statement said.


The ASR program was ­formally ended this month, as the result of a decision by the agency in 2017 to “gradually sunset” the program, according to an FDA statement ­published Friday.

Madris Tomes, a former FDA device reviewer who left the agency and started an independent company to analyze the agency’s public-facing files, said Friday that the decision to revoke the ASR program apparently includes the revocation of an even more obscure program called “retrospective summary reporting,” which was so secret that a spokesperson for Johnson & Johnson once claimed the program did not exist — until presented with a J&J subsidiary’s own filings in the program.

“Consumers can now see what the FDA has seen over the years (i.e. the true numbers of adverse events), and physicians can make better informed decisions about which device(s) to recommend to their patients,” Tomes, CEO of Device Events, said in an e-mail.

Medtronic, the world’s largest medical device company, said Friday that although the company works hard to reduce or eliminate product malfunctions and events, its employees also make every effort to tell regulators, clinicians and the public about malfunctions when they do occur.

“Medtronic has utilized these various reporting programs and our reports and submissions are included in the reports released today by the FDA,” company spokesman Jeffrey Trauring said in an e-mail. “We applaud the FDA for their ongoing efforts to drive transparency and openness around medical device performance, and we will continue to work with FDA on future, modern programs of reporting.”

The filing of an adverse event report is not itself an admission that the device in the report caused the problem. Sometimes the reports include such admissions, but more commonly they simply disclose a medical problem following the use of a medical device, plus a manufacturer’s conclusion that no direct link could be definitively established. Also, the same event may be reported more than once in MAUDE, and the files released Friday may also contain duplicative reports.

AdvaMed, a Washington-based trade group for the med-tech industry, said it was important for physicians and the public to have access to information about medical device performance, and the group supports the FDA’s efforts to make old ASR ­filings public.

“It is important to note, however, that while the ASR information was not accessible in FDA’s MAUDE database, the agency had access to all this information and used that data in its analysis to determine the risk profile of the devices subject to ASR,” AdvaMed spokesman Jim Jeffries said Friday.

Dr. Michael Carome, director of Public Citizen’s health research group, said the FDA should never have created the program. He said allowing summaries gave the appearance that the FDA was serving the device industry, not the public.

“It was easier for the industry to file these reports” rather than individual adverse event reports, Carome said. “But [summaries] hid information. Important safety information was not available to the public. What we need now is for the hidden information to be available and easily searchable.”

The newly released files are not easy to read. The summaries include numerical codes that represent specific problems, because that’s how the device companies were reporting the problems under the ASR program.

There are several different types of summary reporting, and at least one form is still allowed, known as the Voluntary Malfunction Summary Reporting Program.

Med-tech regulatory attorney Mark DuVal said Friday that the move to publish the old summary data was an appropriate way to build public confidence in the reporting system, even though the system wasn’t heavily used in the past.

“Whether the information will be useful to the public, I doubt it,” said DuVal, CEO of DuVal & Associates in Minneapolis. “But the agency is increasingly criticized for stuff like this, and they are avoiding perceptions.”

ASR reports have come under close scrutiny in recent months as the International Consortium of Investigative Journalists and Kaiser Health News have published critical stories about the program’s hidden reports regarding breast implants and surgical staplers. The Star Tribune published a story in December about long-lost reports of problems following the use of Medtronic’s Infuse in upper-spine fusion surgery.

The Washington-based not-for-profit National Center for Health Research welcomed the end of the summary reporting program.

“While we’re very pleased that the FDA has done the right thing by releasing the information as promised, this summary reporting program allowed thousands of serious adverse events involving medical devices to remain hidden from public view,” government affairs director Jack Mitchell said.