Defibrillator recalled among exemptions from the FDA's hidden database

One of these exemptions concerned Sprint Fidelis. In May 2008, an exemption for "corrective measures" was granted – allowed when "the manufacturer took reasonable and appropriate measures to mitigate the problem (s)" and the additional injury reports "will not provide any new information. significant data, "FDA spokeswoman Deborah Kotz said in an email. She stated that the FDA had not granted such an exemption since 2015 and had "effectively terminated the program", and could not say whether these data would soon be available to the public.

The logic of the FDA's approach does not hold in place of patients like Sicklick who have a Sprint Fidelis buried deep in their chest. "Worry about it not working [has] Sicklick, a Long Island Allergy Specialist, N.Y. "I think the FDA should make this information public."

Six high-ranking cardiologists interviewed for this report said they did not know that the FDA had granted Medtronic such an exemption.

"Incredible, truly incredible," said Dr Robert Hauser, a Minnesota cardiologist, whose research has shed light on Sprint Fidelis' high rate of failure. "This is not in the interest of patients who own these devices."

Hauser and other doctors have spent years helping patients manage the risk of living with a cardiac implant that could be harmful to them or to undergo a complicated operation of extracting the device that may prove to be deadly.

The device consists of a pair of wires connected to a defibrillator designed to restore the heart to its normal rhythm. At the time of the recall at the end of 2007, Sprint Fidelis had been implanted in the cardiac tissue of 268,000 patients.

While doctors and patients may voluntarily report device-related problems, the FDA is asking device makers to inform MAUDE of injuries they are aware of – unless there is a problem with the device. exemption.

Medtronic reported having recorded more than 50,000 cases of damage or malfunction during the month of March, with more than one problem reported for some of the 35,000 cases.

Medtronic, which provided data on the exemption of this story, said that its independent quality control group of physicians was reviewing device data since 2007 and that the information was regularly shared with physicians . "Patient safety is our top priority," spokesman Jeffrey Trauring said in an email.

"[Medtronic provides] additional information on performance and product safety in a more comprehensive format than what we receive in summary reports, "said Kotz.

However, none of Medtronic's publications provide details on the 50,000 malfunctions and damage reports the company has filed with the FDA over the last 10 years. These reports, hitherto unrecognized, define the number of lead fractures or cases of inappropriate shocks.

Detective work

A dozen years ago, before Sprint Fidelis was recalled, Hauser was a cardiologist at the Minneapolis Institute of Cardiology. Two patients on one weekend arrived with a fracture of the Sprint Fidelis probe. Hauser said that he had reviewed the records of the center and discovered five similar cases.

He then explored MAUDE and found even more cases. He called Medtronic. He published an article on what he had found, saying "became viral".

On October 15, 2007, Medtronic issued a reminder that the device provided inappropriate shock to some patients and was a "possible or probable" factor in the deaths of five patients. The company subsequently revised the number of deaths to 13.

The thinnest defibrillator wires on the market so far, the researchers said, indicated that Sprint Fidelis' leads were likely to send defective signals to the defibrillator, causing injury to the patient.

The reminder was great news. Patients testified in front of Congress or spoke to reporters of unexpected shocks that looked like a cannon shot in the chest or a horse kick.

The agency acknowledged in a response letter on December 13 that Medtronic was reporting "to the FDA the majority of adverse events" on their implantable defibrillators "globally electronically, via compact discs".

Medtronic's Trauring stated at the time that the company enjoyed an exemption for "alternative summary notification" for cases of lead infections or erosion, which meant that the wires they were moved to the inside of the body.

Six months later, on May 8, 2008, the FDA granted a second waiver to Medtronic, allowing it to report issues critical to the recall, outside of public control.

Trauring said in an email that Medtronic had reported a total of 36,914 cases with 50,205 complications under this second "corrective action".

They include more than 22,000 lead fractures and nearly 2,900 incidents of inappropriate shocks. Trauring said the company had terminated the summary report on November 1, 2018 due to the low volume of issues.

Death cases have not been filed with exempt reports. Since the 2007 recall, more than 2,300 death reports in which the device was supposed to have played a role have been registered with the FDA and are publicly available, according to the MAUDE report. A 2009 report indicates that a patient had 13 painful shocks and then hemorrhage during a surgical operation to remove her defective probe. A lawyer told the FDA that this patient had died a few months later.

In 2012, a patient with a defective device died after tearing a large ship during a surgical operation to remove the lead. In 2015, one patient went to emergency after five shocks, was found to be "exacerbated" by heart failure and died at the hospital four days later, as reported by MAUDE. shows.

Dr. John Mandrola, a cardiologist at Baptist Medical Associates in Louisville, Kentucky, said Sprint Fidelis was the "worst cardiac peripheral problem" he had experienced in 22 years of practice. He said some of his patients had been traumatized by unexpected shocks and the repercussions had lasted for years. The fact that the FDA has not publicly reported the current injury "seems to me problematic," he said. "What is the benefit to the public of an exemption?"

Dr. Frederic Resnic, President of the Division of Cardiovascular Medicine at Lahey Hospital & Medical Center in Burlington, Mbad., And Professor of Medicine at Tufts University, testified before Congress on Device Safety. In an e-mail, he congratulated the FDA for its recent work to modernize the surveillance of medical device safety, but the "lack of communication and transparency" related to the derogation Sprint Fidelis "calls into question the unique role of the FDA as the leading reliable source of information regarding medical device safety. "

Rita Redberg, a professor of cardiology at the University of California at San Francisco and editor of JAMA Internal Medicine, said the FDA had acknowledged that device issues were terribly under-reported.

"Now the FDA intentionally worsens the situation," she said. "I can not think of any justification for that, and I think it's a dangerous practice."