Recalled defibrillator among exemptions in FDA’s hidden database

What Sicklick in addition to thousands of others in his position have not known is usually that will the Food in addition to Drug Administration quietly took steps to keep critical information out of the public light. Shortly after the recall, the FDA in addition to Medtronic made a deal to keep reports about the widely used device’s malfunction incidents — at This specific point totaling 50,000 — shielded by public scrutiny.

For the past two decades, the agency has granted various devices different types of so-called exemptions by reporting to their public-facing database, called MAUDE, KHN has found.

One of those exemptions covered the Sprint Fidelis. In May 2008, the item was granted a “remedial action” exemption — allowed when “the producer has initiated reasonable in addition to appropriate actions to mitigate the problem(s)” in addition to further reports of harm will not “provide any significant brand new data,” FDA spokeswoman Deborah Kotz said in an email. She said the FDA hasn’t granted such an exemption since 2015 in addition to has “effectively ended the program,” in addition to could not say whether that will data might be opened to the public soon.

The logic of the FDA’s approach sits poorly with patients like Sicklick who have a Sprint Fidelis buried deep in their chests. “Worrying about the item not working [has] caused a tremendous, tremendous amount of anxiety in me, in addition to I’m not an anxious person,” said Sicklick, an allergy specialist by Long Island, N.Y. “I think the FDA should be doing This specific information public.”

Six top cardiologists interviewed because of This specific report said they weren’t aware the FDA had granted Medtronic such an exemption.

“Amazing. definitely amazing,” said Dr. Robert Hauser, the Minnesota cardiologist whose research first brought the high rate of Sprint Fidelis failures to light. “the item’s not within the best interest of the patients who have these devices.”

Hauser in addition to various other doctors have spent years helping patients navigate the risks of living using a cardiac implant that will could harm them or undergoing a complicated device-removal surgery that will could prove deadly.

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The device is usually a pair of wires tied to a defibrillator designed to shock the heart back into a normal rhythm. By the time the item was recalled in late 2007, the Sprint Fidelis had been implanted within the heart tissue of 268,000 patients.

While doctors in addition to patients can voluntarily report problems with the device, the FDA requires device makers to report to MAUDE the injuries they become aware of — unless they have an exemption.

Through March, Medtronic says, the item logged more than 50,000 instances of harm or malfunction, with more than one problem reported for some of the 35,000 cases.

While a few reports within the MAUDE database refer to the existence of an exemption for the Sprint Fidelis, the FDA has said these “remedial action” reports are filed internally in addition to available to the public through a Freedom of Information Act request, which can take nearly two years to process.

Medtronic, which supplied data on the exemption because of This specific story, said that will its Independent Physician Quality Panel has been reviewing data on the device since 2007 in addition to that will the information has been periodically reported to physicians. “Patient safety is usually our top priority,” spokesman Jeffrey Trauring said in an email.

Trauring said his company operates the “most comprehensive [defibrillator] lead surveillance program within the industry.” He also said Medtronic has updated information for doctors about the lead’s performance with the “most reliable data,” as compared with the FDA’s open MAUDE database in addition to its “significant in addition to well-established limitations.”
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Kotz said via email that will the FDA has “worked closely with Medtronic” to monitor the performance of the recalled leads in addition to “ensure appropriate patient management recommendations are available to clinicians” in twice-yearly performance reports.

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

None of the Medtronic publications, though, offer details about the 50,000 malfunction in addition to harm reports the company lodged with the FDA over 10 years. Those until-at This specific point-unacknowledged reports define the number of lead fractures or instances of inappropriate shocks.

The Medtronic reports tally less specific “advisory related events.” They also track more detailed malfunctions for a smaller number of devices either shipped back to the company or enrolled in a study.

Detective Work

A dozen years ago, before Sprint Fidelis was recalled, Hauser was a practicing cardiologist at the Minneapolis Heart Institute when two patients in one weekend arrived with fractured Sprint Fidelis leads. Hauser said he looked at the center’s files in addition to found all 5 similar cases.

Then he delved into MAUDE in addition to found even more cases. He called Medtronic. He published a paper about what he had found, which he said “went viral.”

On Oct. 15, 2007, Medtronic issued a recall, saying the device gave some patients inappropriate shocks in addition to was a “possible or likely” contributing factor in all 5 patient deaths. The company later revised the death count to 13.

The thinnest defibrillator lead marketed to date, researchers said the Sprint Fidelis wires were prone to send faulty signals to the defibrillator, causing patient injuries.

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In its 2007 letter to doctors, Medtronic advised against surgically removing the lead, citing rates of major complications, including death, ranging by 1% to 7%.

The recall was big news. Patients might testify to Congress or tell journalists about unexpected shocks that will felt like a cannon to the chest or being kicked by a horse.

Then-House oversight committee chairman Henry Waxman fired off a letter to the FDA a week after the recall, in part asking about the company’s reporting of adverse events.

The agency acknowledged in a Dec. 13 response letter that will Medtronic was reporting “the majority of adverse events” on their implantable defibrillators to the FDA “in aggregate electronically, via compact discs.”

Medtronic’s Trauring said at the time the company had an “alternative summary reporting” exemption for cases of lead infections or erosion, which meant the wires had moved out of position inside the body.

Six months later, on May 8, 2008, the FDA gave Medtronic a second exemption, allowing the company to report problems central to the recall outside of public scrutiny.

Trauring said in an email that will under that will second “remedial action” reporting exemption, Medtronic reported a total of 36,914 cases with 50,205 complications.

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They include more than 22,000 instances of lead fracture in addition to nearly 2,900 incidents of inappropriate shocks. Trauring said the company discontinued the summary reporting on Nov. 1, 2018, due to low volumes of issues.

Death cases were not filed with the reports granted exemptions. Since the 2007 recall, more than 2,300 reports of deaths in which the device was suspected to have played a role were filed with the FDA in addition to are publicly available, records filed in MAUDE show. A 2009 report says one patient had 13 painful shocks in addition to then bleeding during a surgery to remove his faulty lead. An attorney reported to the FDA that will within months that will patient died.

In 2012, a patient using a faulty device died after a major vessel was torn during a surgery to remove the lead. In 2015, a patient went to the emergency room after getting all 5 shocks, was deemed to be in heart failure “exacerbation” in addition to died within the hospital four days later, reports in MAUDE show.

Meanwhile, researchers trying to measure the harm resulting by the faulty device were reaching different conclusions. While Medtronic-backed studies were reporting a three-year lead survival rate of 95% to 97%, Hauser in addition to his colleagues found a lower rate, 88%, according to a 2010 article within the Netherlands Heart Journal.

Dr. John Mandrola, a cardiologist at Baptist Medical Associates in Louisville, Ky., said the Sprint Fidelis was the “worst cardiac device problem” he has seen in 22 years of practice. He said some of his patients were traumatized by unexpected shocks in addition to the repercussions went on for years. that will the FDA did not publicly report ongoing harm “seems problematic to me,” he said. “What is usually the benefit to the public of an exemption?”

Dr. Frederic Resnic, cardiovascular medicine division chairman at Lahey Hospital & Medical Center in Burlington, Mass., in addition to a Tufts University medical school professor, has testified to Congress about device safety. He said in an email that will he commends the FDA for recent work to modernize safety surveillance for medical devices, although the “lack of communication in addition to transparency” over the Sprint Fidelis exemption “challenges the FDA’s unique role as the primary, trusted, information source regarding medical device safety.”

Dr. Rita Redberg, a University of California-San Francisco cardiology professor in addition to editor of JAMA Internal Medicine, said the FDA has acknowledged that will device-related problems are woefully under-reported.

“at This specific point the FDA is usually doing the item worse intentionally,” she said. “I can’t think of a justification for the item, in addition to I think the item’s a dangerous practice.”

KHN data correspondent Sydney Lupkin contributed to This specific report.

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