Sprint Fidelis Leads, which are manufactured by Medtronic Inc., are specific models of cardiac electrodes (thin wires) that connect implantable cardioverter-defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) directly to the heart. Defibrillators are medical devices that treat abnormally fast heart rhythms (fibrillation) by administering preset electrical shocks.

Medtronic Sprint Fidelis leads were first released on the market in 2004. As of October 4, 2007, approximately 268,000 people were implanted with Sprint Fidelis leads worldwide, including 172,000 Sprint Fidelis leads implanted in the United States.

Medtronic Sprint Fidelis Lead Defect

Medtronic recently issued a warning to physicians and patients with

defibrillators that a defect discovered in Sprint Fidelis leads may have caused at least five patient deaths. Specifically, Medtronic announced that some Sprint Fidelis leads have been shown to fracture, resulting in inadequate or ill-timed electric shocks to patients. When the defective Sprint Fidelis leads break, two unfavorable results are possible:

  • 1. a shock may be administered when it shouldn’t be, or
  • 2. there may be no shock administered when a shock would be appropriate or needed

FDA Recommendations for Patients with Sprint Fidelis LeadsAccording to the FDA, patients who have had the Sprint Fidelis lead implanted should contact their physician, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations. On the other hand, the FDA says that patients should not routinely seek removal of the device, because the risk of removal in most patients exceeds the small risk of Sprint Fidelis lead fractures.

Patients with Sprint Fidelis leads have two alternatives to removing the lead. First, patients can continue using the Sprint Fidelis leads while monitoring closely for signs of fracture. Second, patients can surgically add a replacement lead. Adding a replacement lead does not require removing the Sprint Fidelis lead. However, if a Sprint Fidelis lead is left in a patient without being used, the tip must be covered with a small plastic insulation.

Medtronic Sprint Fidelis Lead Lawyer

If you or a loved one received a defective Sprint Fidelis lead, contact us today to learn about your legal rights and options.

Published November 17, 2011 by