“It often takes months or even years for the F.D.A. to detect patterns of failure,” said Jack Mitchell, director of health policy for the National Center for Health Research in Washington. “Post-market surveillance of medical devices continues to be dangerously slow and clearly inadequate to protect patients from risky devices.”

The agency has acknowledged that it has a problem.

Dr. Jeffrey E. Shuren, director of the agency’s Center for Devices and Radiological Health, called the current reporting system “passive surveillance.” Regulators rely on manufacturers and hospitals to notify them of injuries, infections and other adverse events linked to medical devices, as well as malfunctions. The guidelines call for alerting the F.D.A. no longer than 30 days after an incident.

Both the F.D.A. and the Government Accountability Office are unable to define what percentage of problems go unreported. Dr. Shuren has said failure to report is “likely common.” Manufacturers are required to notify the F.D.A. about device-related deaths and serious injuries; hospitals are required to report suspected medical-device-related deaths to the manufacturer and the F.D.A. but can report serious injuries only to the manufacturer. Doctors, who are often the first to recognize a device-related problem, are not required to alert the F.D.A. And studies show that many do not bother.

“There are approximately 65,000 new adverse events every month, and you don’t have enough analysts to review those reports,” said Madris Tomes, who worked on such reports at the agency from 2010 to 2014. “They read them typically in order of importance, starting with deaths and injuries and malfunctions. When they come in the next day, they once again start with new deaths and injuries and malfunctions.”

Image One of the cardiac defibrillators recalled by the F.D.A. over faulty batteries. Credit... St. Jude Medical

Mr. Whitaker said no one had told him that the F.D.A. was not equipped to deal with the volume. “That wasn’t raised to our attention in all of our negotiations,” he said. “Are they understaffed? If they are, they should tell us and then we can have a conversation about it.”

The negotiations, which last about a year and involve Congress, the F.D.A. and lobbyists for device companies, are contentious.