Medtronic Sprint Fidelis® Defibrillator Lead Recall Lawsuit

Medtronic has suspended sales of the Sprint Fidelis family of defibrillator leads because of the potential for lead fractures, reports of at least 5 patient deaths and other serious, life-threatening complications.

The Sprint Fidelis lead has been implanted in approximately 268,000 people worldwide. The Sprint Fidelis lead may have also been used to connect defibrillators manufactured by other companies such as Guidant, Boston Scientific, and St. Jude.

The U.S. Food & Drug Administration (FDA) is recommending that patients who have had the Sprint Fidelis lead implanted should contact their physician immediately, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations.

If you or a loved one have been injured by the Medtronic Sprint Fidelis lead, you should contact us immediately. You may be entitled to compensation and we can help.

What’s the problem?

On October 15, 2007 Medtronic announced it was voluntarily suspending distribution of its Sprint Fidelis defibrillation leads because of reports of fractures leading to serious complications including at least 5 deaths.

“Fractures in the Sprint Fidelis leads may lead to audible alerts, inappropriate shocks and the loss of output,” Medtronic said.

Medtronic first notified physicians in March 2007 about the fracture rate at that time and the proper method for implantation. Additional data on adverse events accumulated since then has prompted the Sprint Fidelis recall.

U.S. Food & Drug Administration (FDA) Sprint Fidelis Recall Video

Below is an excellent video published by the U.S. Food & Drug Administration (FDA), which warns patients and physicians that Medtronic has stopped distributing certain models of the Sprint Fidelis defibrillator lead, as the leads have the potential to fracture, which could lead to death or defibrillator malfunctions.

Read the Full Transcript: Recall of Sprint Fidelis Cardiac Leads

Medtronic Sprint Fidelis Recall List

The following model numbers of the Sprint Fidelis® family of defibrillator leads have been recalled:

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

The Sprint Fidelis lead may have also been used to connect defibrillators manufactured by other companies such as Guidant, Boston Scientific, and St. Jude.

Signs of Lead Fracture / Breakage

In the circumstance where a lead malfunctions, breaks, or “fractures,” the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered.

Do I have a Medtronic Sprint Fidelis® Lawsuit?

The Medical Device and Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Medtronic lawsuits. We are pursuing individual litigation nationwide and currently accepting new Medtronic Sprint Fidelis® defibrillator lead cases in all 50 states.

If you or a loved one have been injured by the Medtronic Sprint Fidelis lead, you should contact us immediately. You may be entitled to compensation and we can help.