FDA security scandal: 50,000 hidden reports of dysfunction of a cardiac device

According to a series of surveys conducted by Kaiser Health News, the Food and Drug Administration has authorized the manufacturer of a defective implantable cardiac device to secretly record 50,000 incidents of malfunction.

The device – Sprint Fidelis, manufactured by Medtronic – consists of a pair of wires and a defibrillator that allows the heart to regain a steady rhythm. But doctors discovered that it gave patients random, harmful and sometimes even heart failure zaps.

Medtronic recalled the device in 2007, but only after implantation in approximately 268,000 patients. Since then, many of these patients have had the appalling choice of learning to live with the defective device or to undergo invasive, risky – sometimes life-threatening – surgery to remove it. According to the KHN survey, they made this choice without information from the 50,000 incident reports.

Malfunction reports for devices such as the Spring Fidelis are typically saved in an FDA database for the public, called MAUDE (manufacturer and user user facility). However, the agency has quietly put in place a repository of "alternative synthesis reports" and has granted notification exemptions for a wide variety of medical devices for decades. The agency has since accumulated millions of incident reports out of public view. This includes the 50,000 reports for Sprint Fidelis. Since 2016, the FDA's repository has recorded at least 1.1 million reports of incidents and injuries resulting from malfunctions of medical devices, KHN found.

The alternative reporting repository has apparently been put in place to reduce the paperwork of redundant incident reports. But its existence and use have been kept in the shadows, many doctors, consumer rights advocates, and even some high-ranking FDA employees have completely ignored its existence. Now that they are aware, doctors and human rights advocates claim that the hidden reports have kept the necessary safety data from patients trying to accurately assess and weigh their risks.

"It's not in the best interest of patients who own these devices," said Dr. Robert Hauser at KHN. Hauser, a Minnesota cardiologist, was one of the first to worry about Sprint Fidelis. After learning that the FDA had granted Medtronic a MAUDE reporting exemption for Sprint Fidelis, Hauser replied, "Incredible. Truly unbelievable."

The list of exempt devices includes current and controversial devices. Some of these are typically implanted in patients and used in routine surgeries, such as pelvic mesh, surgical staples, balloon pumps to improve circulation, respirators and breast implants.

As a result of the KHN investigation, the FDA announced that it would close the "other summary reports" repository and end the exemptions. Dr. S. Lori Brown, a former FDA official, told KHN that this decision was a "win for patients and consumers".