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FDA security scandal: 50K hidden reports of cardiac malfunction

  The head office of the Food and Drug Administration in White Oak, Md.
Enlarge / The head office of the Food and Drug Administration in White Oak, MD.

The Food and Drug Administration allowed the maker a defective implantable heart device to secretly log 50,000 error events, according to a number of studies by the Kaiser Health News.

The device ̵

1; Sprint Fidelis, manufactured by Medtronic – consists of a few wires and a defibrillator to push the heart into a regular rhythm. But doctors found that it gave patients random, harmful zaps and sometimes failed in actual heart conditions.

Medtronic recalled the device in 2007, but only after it was implanted in about 268,000 patients. Many of these patients have since faced the terrible choice of learning to live with the defective unit or undergoing an invasive, risky-sometimes deadly operation to remove it. According to the KHN study, they made the choice without information from the 50,000 event reports.

Error reports for devices such as Spring Fidelis are typically recorded in a public FDA database called MAUDE (manufacturer and user experience). However, the Agency set up an "alternate summary reporting" register and for decades granted concessions for a wide range of medical devices. The Agency has since stacked millions of incident reports out of public opinion. It includes the 50,000 reports to Sprint Fidelis. Since 2016, the FDA's repository has added at least 1.1 million reports of incidents and injuries as a whole from medical device malfunctions, KHN found.

The alternative reporting store was apparently created to cut down on paperwork for redundant event reports. But its existence and use have been kept in the shadows, with many doctors, consumer advocates, and even some senior FDA staff remained unaware of its existence. Now, as they are aware, doctors and lawyers say the hidden reports have kept the necessary safety data from patients trying to measure and weigh their risks.

"It is not in the best interest of the patients who have these devices". Robert Hauser told KHN. Hauser, a Minnesota cardiologist, was one of the first to raise concerns about Sprint Fidelis. After learning that the FDA had given Medtronic a MAUDE reporting release for Sprint Fidelis, Hauser replied, "Amazing. Really amazing."

The list of exempted entities contains common and controversial entities. Some of these are typically implanted into patients and used in common operations such as pelvic, surgical staples, balloon pumps to enhance circulation, respiratory protection, and breast implants.

After KHN's investigation, the FDA announced that it would shut down "alternative summary reporting" depot and terminate exemptions. Former FDA official Dr. S. Lori Brown told KHN that the move is a "victory for patients and consumers."

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