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Patient Treatment Guide: Defibrillators | FDA Issues Nationwide Recall of Medtronic Sprint Fidelis Defibrillators

Medtronic Recalls Defibrillation Leads

On October 15, 2007 Medtronic recalled its Sprint Fidelis defibrillation leads from the market saying the leads can fracture causing serious injuries and death. Medtronic said the Sprint Fidelis leads are already linked to at least 5 deaths. The Sprint Fidelis leads are used to attach a defibrillator or pacemaker to the heart. The leads can be used with defibrillators and pacemakers manufactured by Medtronic as well as other manufacturers like Guidant and St. Jude.

If a defibrillator lead fractures it can cause unnecessary shocks to the heart or fail to provide shocks at all. If you or a loved one has an implanted defibrillator or pacemaker you may have valuable legal rights. Please complete a legal case evaluation form on the left side of this page or call 1-866-50-RIGHTS (1-866-507-4448) to have an attorney review your case today.

Recalled Medtronic Defibrillation Leads

  • Sprint Fidelis 6930
  • Sprint Fidelis 6931
  • Sprint Fidelis 6948
  • Sprint Fidelis 6949

Risks Associated with Recalled Leads

  • Frequent unnecessary shocks
  • Failure to shock when necessary
  • Need to surgically replace leads
  • Potential of permanent heart damage

 

Over 235,000 Defibrillator Patients at Risk

The Sprint Fidelis defibrillator leads were approved in September 2004, and it is estimated that approximately 235,000 leads have been implanted since their launch. Medtronic estimated that about 2.3 percent of patients with the Fidelis lead, or 4,000 to 5,000 people, would experience a lead fracture within 30 months of implantation. However, this number will likely be higher as the risk of fracture may increase over time.

Free Lawsuit Consultation

If you have a Defibrillator or a Pacemaker and you have received unnecessary shocks or your device has failed you may have defective cardiac leads. You should contact your physician as possible to inquire what type of defibrillator leads are attached to your device. If you have teh Sprint Fidelis leads, your doctor may recommend for that they be removed or replaced. If you would like more information on the recalled defibrillator leads, and to learn about your legal rights, please call 1-866-507-4448 or submit an evaluation form on the left side of this page.

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