Details of a Medical Device Recall Kept Secret by the FDA’s Secret Reporting Pathway

medical device recall

The details of a medical device recall involving an implantable defibrillator is alarming to say the least.  The Sprint Fidelis, an internal defibrillator, is one of an unknown number of malfunctioning medical devices the U.S. Food and Drug Administration (FDA) kept hidden from the public via a confidential adverse event reporting pathway.  When the manufacturer issued a medical device recall in 2007 more than 250,000 patients had already been implanted with the defibrillator.

Now, patients implanted with the Sprint Fidelis are facing a choice – undergo a life-threatening removal surgery, or live with the risk of a possibly malfunctioning defibrillator.  Either way, American lives are in danger, and members of the medical community think the FDA’s secret reporting pathways are to blame.

Increasingly Shocking Details about the FDA’s Hidden Database

Drug and Device Watch has previously reported on the revelation of the FDA’s hidden database.  The FDA is reportedly committed to making all of the confidential information public over time.  As new details emerge, the sheer number of consumers who have suffered from malfunctioning medical devices is staggering.

Since 2016, the FDA allowed device manufacturers to secretly report 1.1 million injuries or malfunctions via the hidden database.  These adverse event reports were not made public, and apparently did not result in needed recalls for some devices.

Medical Device Recall: The Sprint Fidelis

The Sprint Fidelis is a defibrillator and two wires that are meant to stay in the heart muscle permanently.  The goal of a defibrillator is to shock an abnormally beating heart into a healthy rhythm.  Before the manufacturer, Medtronic, issued its recall, 268,000 patients received the device.

Medtronic issued the recall once it became known that the device could shock patients at random and also sometimes to fail to shock them in the event of true cardiac crises.  In the recent revelations about the FDA’s secret reporting pathways, we have learned the agency received at least 50,000 reports of adverse events associated with the Sprint Fidelis.  These reports were not made public prior to the initiation of the medical device recall.

The recall itself caused a major uproar.  Congress conducted an investigation during which patients testified that the malfunctioning device felt like being kicked by a horse or shot with a cannon.  Though the House of Representatives demanded an explanation from the FDA, the agency simply confirmed Medtronic was following the procedures established within the alternative summary program and were in full compliance with the FDA’s reporting procedures.

Device Reporting Exemptions

The malfunctioning defibrillator is just one of the many unsafe medical devices granted an exemption from public scrutiny and allowed to use the “alternative summary reporting” system.  Since this reporting pathway and hidden database have come to light, the FDA has faced harsh backlash.  Within weeks, the agency shutdown the 20-year-old alternative summary reporting program.  A spokesperson from the FDA says the agency has not granted an exemption to use the alternative summary program since 2015.

The Sprint Fidelis Exemption

Medtronic benefitted from the questionable exemptions from public reporting that the FDA granted.  Their exemptions actually took effect after the manufacturer initiated the recall.  The first came almost immediately after the recall, and the second a month later.

With the blessing of the FDA, and despite their public recall, Medtronic successfully hid more than 50,000 adverse events from the public, including:

  • 22,000 instances of wire breakage, which would cause the device to fail
  • Almost 2,900 incidents of inappropriate electric shocks

According to the FDA, Medtronic received its exemptions because, “the manufacturer has initiated reasonable and appropriate actions to mitigate the problem(s),” and publishing reports of injury or harm will not “provide any significant new data.”

Handicapping the Medical Community

The doctors and surgeons who rely on FDA data on a day-to-day basis suggest that secrecy prevents them from doing what is in their patients’ best interest.  According to a CNN report, some of the country’s top cardiologists did not know that Medtronic had a reporting exemption.  That also means these doctors didn’t know about the additional 50,000 patients injured by the Sprint Fidelis.

Who needs these statistics more than the doctors who may actually use the medical devices on patients? Without accurate information or a medical device recall, physicians can unwittingly prescribe, use, or even permanently implant a potentially deadly medical device.

How the Sprint Fidelis Failures Came to Light

Dr.  Robert Hauser is the cardiologist whose research revealed the devastation caused by the Sprint Fidelis.  More than a decade ago when the Sprint Fidelis was in regular use, Dr.  Hauser treated two patients in one week who experienced the device malfunctioning.  He did his own research, eventually publishing a paper and then continuing research that showed:

  • Hospital records where he practiced showed five similar cases.
  • There was a 12 percent rate of wire breakage after three years
  • Medtronic filed adverse event reports about the device that could not disappear into the hidden database – the reports of patient deaths.
  • There were 13 deaths associated with the Sprint Fidelis, which were admitted by Medtronic.
  • Since 2007, more than 2,300 deaths have been linked to the device.

Since his discovery and the subsequent medical device recall, Dr.  Hauser has spent his career helping patients navigate the nerve-wracking reality of living with a recalled medical device.  Both the FDA and the manufacturer advise against surgically removing the defibrillator referring to the high risk of mortality from the removal surgery, which could be as high as seven percent.

Deaths Associated with Defibrillator Medical Device Recall

While journalists and physicians wait for the FDA to release all of the hidden information in the database, the publicly available information in MAUDE gives a glimpse into what will eventually come to light.  Device manufacturers have never been able to secretly report adverse events that resulted in death.  As a result, CNN gathered information and reported these events from the public database:

  • One patient in 2009 received 13 painful shocks.  During removal surgery to remove the faulty wire, the patient suffered severe bleeding.  The patient died within months.
  • A patient in 2012 died after suffering a tear to a major blood vessel during an attempted device removal surgery. The surgery was to remove a defibrillator that had been malfunctioning.
  • A patient in 2015 went to an emergency room, where doctors observed him receive five shocks.  He died in the hospital four days later.

Medical Device Recall Attorneys

The medical and legal communities remain baffled at the lengthy and meticulous cover-ups facilitated by the FDA via the alternative reporting system.  Without all the facts, it’s impossible to guess the scope and loss of life and comfort caused by the secrecy.  It seems likely that more horrific information about the suffering caused by malfunctioning medical devices will come to light in the coming years.

If you or someone you love uses a device included in a medical device recall, it is important to understand just what that means.  Sometimes, there is a solution for device malfunctions that can be done at your local hospital.  Other times, there are important decisions to be made about your health.  In any of these circumstances, Drug and Device Watch can help.

Call 1-888-458-6825 today to schedule your free consultation, or contact us online.  We can offer information about your legal rights so you can make the best, most informed decisions possible.