Defective Medtronic Sprint Fidelis Leads

Defibrillator Leads can Fracture

Defibrillator leads are cardiac electrodes used to connect a defibrillator or a pacemaker to the heart. Defibrillator leads pass vital information to and from these cardiac devices. The information transmitted through these leads can prompt a defibrillator to send shocks through the same leads to the heart, which can help regulate a person's heartbeat. When a defibrillator lead fractures, it can comprise both the flow of information to the device, as well as, the shock sent from the device to the heart. This can cause a defibrillator to send unnecessary shocks or not send shocks when it is necessary.

What is a Sprint Fidelis Defibrillator Lead?

Sprint Fidelis Leads are manufactured by Medtronic, Inc, and are specific models of cardiac electrodes (thin wires) that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart.

The FDA approved the Sprint Fidelis leads in September 2004, and it beceame instantly popular with doctors because it is thin and nimble, which make implanation much easier. However, the thin size of the Sprint Fidelis leads are likely part of the reason why they tend to fracture and tear. The problems associated with Sprint Fidelis leads have not been a problem with thicker leads, including Medtronic's Quattro leads.

When Did Medtronic Discover the Problem?

In late March 2007, Medtronic Inc. sent a letter to doctors advising them that the wire leads in a line of widely used heart defibrillators could tear at a "higher than expected" rate. While Medtronic informed the FDA about the lead fracture problem and issued a "Dear Doctor" letter, the company did not send letters to patients, iissue news release, and did not list an advisory on its website. The company operated under the assumption that patients would likely hear of potential problems through their doctors. The failure to publically notify existing patients, also put future patients at risk as thousands of defective leads were implanted in patients between March and October, when the leads were finally recalled.

Patients with Sprint Fidelis Leads Should Explore Legal Options

Patients concerned about their defibrillator leads should contact their doctors as soon as possible. Many patients with defective devices have been contact by their doctors or received a letter from Medtronic. However, many patients with the recalled leads have not received notification from their doctors or Medtronic. If you are at all concerned you should contact your treating physician immediately.

If you do have recalled leads implanted, you should explore your legal options. Replacing these leads is both risky and expensive and our law firm will aggressively represent you to ensure that justice is done. You can request a free legal consulation by completing the submission form on this page or by calling Mark & Associates, P.C. at 1-866-9-MEDTRONIC.