In May 2008, a year after Medtronic (NYSE:MDT) recalled its Sprint Fidelis defibrillator leads, the company and the FDA struck a deal that would keep a total of 50,000 reports of device malfunctions related to the leads hidden from the public, according to a new Kaiser Health News report.
The 50,000 reports are part of approximately 1.1 million that the FDA has allowed devices makers to file through so-called exemptions from reporting to their public-facing MAUDE database, which KHN had previously reported on in March.
The Fridley, Minn.-based medtech giant was granted its own “remedial action” exemption for the Sprint Fidelis leads, intended for when “the manufacturer has initiated reasonable and appropriate actions to mitigate the problem(s)” and in which new reports of harm would not “provide any significant new data,” FDA spokesperson Deborah Kotz told the news outlet in an email.
The exemption was last used in 2015 as the program has “effectively ended,” according to the KHN report. Despite the program ending, the FDA could not say whether the data would become available to the public.
Of six top cardiologists KHN spoke to, none knew that Medtronic had received an exemption allowing them to hide critical malfunction data from the public, including healthcare professionals who rely on it to make informed decisions about patient care.
“Amazing. Really amazing. It’s not in the best interest of the patients who have these devices,” Minnesota cardiologist Dr. Robert Hauser, whose research first brought attention to the high rate of failure with the Sprint Fidelis leads, said in the report.
Through to March, Medtronic says it logged more than 50,000 instances of harm or malfunction related to the leads, with more than a single problem reported for more than 35,000 of the cases, according to the KHN report.
Medtronic said that it has been reviewing data on the Sprint Fidelis leads since 2007 and claims that “patient safety is our top priority,” according to the report.
Despite this, none of Medtronic’s publications offer details about the 50,000 hidden reports logged with the FDA over 10 years – data which defines the number of lead fractures or instances of inappropriate shocks, according to the KHN report.
Since the 2007 recall, more than 2,300 reports of deaths which indicate a possible connection to the leads were filed with the FDA and are publicly available.
Louisville, Ky.-based cardiologist Dr. John Mandrola called the Spring Fidelis leads the “worst cardiac device problem” he has seen in 22 years, according to the report. He went on to state that he believed the FDA granting an exemption excluding them from public scrutiny “seems problematic to me.”
“What is the benefit to the public of an exemption?” Mandrola told KHN.
Dr. Frederic Resnic of Burlington, Mass.-based Lahey Hospital & Medical Center and Tufts University Medical School, who has testified to Congress about device safety, told KHN that the “lack of communication and transparency” over the leads “challenges the FDA’s unique role as a primary, trusted information source regarding medical device safety.”
Medtronic said that the company only stopped the summary reporting of issues related to its Fidelis leads on November 1, 2018 – and only due to a low volume of issues, according to the report.
Dr. Rita Redberg, an editor for JAMA Internal Medicine and cardiology professor at the University of California-San Francisco told KHN that device-related problems are “woefully” under-reported.
“Now the FDA is making it worse intentionally. I can’t think of a justification for it, and I think it’s a dangerous practice,” Redberg said, according to the report.
