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# Hill Interest Grows Over Late Device Adverse Events
- URL: https://www.fdaweb.com/hill-interest-grows-over-late-device-adverse-events/
- Published: 2016-10-21T12:00:00.000Z
- Updated: 2026-09-14T21:41:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137139

Sen. **Al Franken** (D-MN) continues to monitor FDA’s handling of late medical device adverse events from manufacturers amid a growing controversy that new reporting mechanisms and guidelines are needed. A recent Minneapolis *Star Tribune* [article](https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=newssearch&cd=1&cad=rja&uact=8&ved=0ahUKEwiRgp6MsuzPAhXJFj4KHXmcAugQqQIIHCgAMAA&url=http%3A%2F%2Fwww.startribune.com%2Ffda-protocols-allow-medical-device-makers-to-keep-adverse-events-out-of-view%2F397) revealed the agency’s use of a “retrospective summary reporting” program, under which companies have disclosed more than 300,000 late adverse events. The article is a follow-up from an April *Star Tribune* investigative report that criticized Medtronic’s alleged failure for many years to submit an adverse event database on its Infuse bone fusion product ([see earlier story](https://www.fdaweb.com/medtronic-challenges-infuse-media-report/)).

Summary reporting has been in use for years and helps save the agency from receiving redundant reports. “We have regulations (21 CFR 803.19) and a process that allow for an exemption or alternative to reporting requirements under 21 CFR 803, such as allowing summary reporting in lieu of individual reporting,” FDA [recently told](https://www.fdaweb.com/no-new-info-in-late-infuse-reports-fda/) Franken in response to his concerns. “Because the types of events in these reports were similar to events seen in other reports received from 2006-2013, FDA determined that receiving individual reports would add little to our current understanding of the benefit-risk profile for the device.”

Retrospective summary reporting is different. An FDA spokeswoman told the *Tribune* that retrospective reports involve material that turns up during “a retrospective review of a firm’s complaint file.” The reports might cover service technician logs or old call-center activity. They could come when one company acquires another and finds unreported problems in its files. Or they can happen when a company re-scans old records after a warning from the FDA to change its reporting process.

In response to the latest revelations, Franken said the FDA’s system for monitoring devices is more generally flawed, beyond the retrospective summary reports, and called for change. “Patients and physicians need to have access to all relevant safety information to make the best decisions about the right course of treatment,” he said. “But right now, that doesn’t always happen. That’s why I’ve been pushing to revamp our medical device reporting system.”

Sen. **Amy Klobuchar** (D-MN) said the retrospective summary reporting program “stands in the way” of keeping the public informed. Typically FDA makes only a few sentences of summary material available to the public, while information on individual adverse events stays confidential. “All patients deserve to know the risks and side effects of a medical procedure and a medical device,” Klobuchar told the *Tribune*. “The current reporting system should be strengthened to ensure patients have critical information about products as quickly and efficiently as possible.”

Public Citizen’s Health Research Group says it welcomes the Congressional interest in this issue, “which represents just one of the many ways in which the current medical device reporting system is flawed.” Companies have “failed to meet their reporting deadlines, and rather than penalizing them, the FDA is allowing them to submit less information than would ordinarily be required under the law,” Public Citizen health researcher **Sarah Sorscher** told ***FDA Webview*** 10/21\. “So now the public has reports that are not only late, but also incomplete.”

Meanwhile, AdvaMed has defended the summary reporting practice. “The medical technology industry is committed to patient safety and compliance with all FDA regulations including postmarket reporting,” the group said in a statement. “Retrospective analysis and potential reporting of events is appropriate and allowed by FDA for a variety of reasons including implementation of the company’s quality management system.”