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50,000 Malfunction Reports for Recalled Defibrillator Hidden in FDA’s Database

Medtronic and the Food and Drug Administration (FDA) have been hiding malfunction and injury reports about the recalled Sprint Fidelis since it was granted an exemption in 2008, according the CNN.

About the Sprint Fidelis Recall

The Sprint Fidelis is an implantable cardioverter-defibrillator created to shock the heart in order to regulate its rhythm.

According to CNN, the device was recalled Oct. 15, 2007 for shocking at inappropriate times and being a likely contributor in 5 patient deaths, later changed to 13.

At the time of its recall, the product had already been implanted in the heart tissue of 268,000 patients.

Medtronic advised against having the lead surgically removed to prevent major complications, including death.

Sprint Fidelis Injury Reports

Since the product’s recall, over 50,000 reports have been made about the product malfunctioning and causing injury.

Many of the reports—over 35,000 cases—involved more than one issue with the device. Issues included 2,900 incidents of inappropriate shocks and 22,000 instances of lead fractures.

Despite these serious statistics, the public was kept unaware of the product’s high likelihood to malfunction due to an exemption the FDA issued to Medtronic in 2008.

The FDA’s Exemption for the Sprint Fidelis

For 20 years, the FDA has been granting various devices certain exemptions from reporting to MAUDE, their public-facing database, according to KHN.

One of those exemptions was granted to the Sprint Fidelis on May 8, 2008. According to CNN, this “remedial action” exemption allowed new reports about the product’s malfunctioning or causing injury to be hidden from the public.

The reasons provided by the FDA to justify this action were that the manufacturer had already taken all possible steps to stop the problems and that the additional data would not provide any new significance.

However, hiding this information from the public caused many people who already had the defibrillator inside their bodies to be unaware of its high likelihood to malfunction and cause injury or death.

Harm Caused by the Sprint Fidelis Since Recall

Information provided by CNN:

  • 36,914 cases
  • 50,205 complications
    • 22,000 instances of lead fracture
    • 2,900 incidents of inappropriate shocks
    • 2,300 reports of death

Hurt by a Defective Medical Device? Contact Thomas J. Henry

Defective and faulty medical devices have the potential to cause long-lasting and permanent damage in patients seeking treatment for their injuries and illnesses. In some cases, defective medical devices have caused fatal injuries, causing devastation to the victim’s family. At Thomas J. Henry, we will fight vigorously on you and your family’s behalf. We have the legal and financial resources necessary to properly develop your case and take on the large pharmaceutical and medical device manufacturers.

If you or a loved one have been injured by a medical device, call us today — attorneys are available 24/7, nights and weekends. Our firm has offices in Corpus ChristiSan Antonio, Austin, and Houston, serving clients across Texas and nationwide.

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