Medtronic Sprint Fidelis Defibrillator Leads

The Food and Drug Administration (FDA) issued a Class 1 Recall on Medtronic, Inc. Sprint Fidelis® Defibrillator Leads on October 17, 2007. This recall came one day after the FDA issued a safety alert announcing Medtronic's decision to voluntarily suspend distribution of its Sprint Fidelis defibrillation leads because of a small number of detected fractures.

Defibrillators are medical devices implanted to monitor heart rhythms. The devices keep the heart from going too fast by delivering an electrical shock or rapid pacing to restore the heart to its normal rhythm when dangerous, irregular heartbeats are detected. When a defibrillator is implanted, it is connected to the heart using leads, such as Medtronic's recalled Sprint Fidelis leads. Medtronic's recalled Sprint Fidelis leads may be used not only in connecting Medtronic defibrillators to the heart, but also in connecting Guidant, Boston Scientific, and Saint Jude devices to the heart.

The Medtronic Sprint Fidelis Defibrillator Leads have been recalled because of the potential for lead fractures. If a heart device lead fractures, it can cause the defibrillator to deliver unnecessary shocks or to not operate at all. Some deaths or other serious injuries have been reported where a lead fracture may have been a possible or likely contributing factor.

The FDA reports that fractures have occurred in less than 1 percent of the 268,000 Medtronic Sprint Fidelis leads implanted worldwide. The FDA and Medtronic, Inc. do not recommend replacement of the leads at this time; however, the FDA and Medtronic do recommend that you contact your doctor if you believe you may have a recalled lead, especially if you have experienced multiple shocks, lightheadedness, fainting, or palpitations. Your doctor may be able to increase monitoring to detect fractures early, or may recommend a second surgery to add a lead and to "cap" the recalled lead.

The four models of the Medtronic Sprint Fidelis Leads currently recalled begin with 6930, 6931, 6948, and 6949. According to the FDA and Medtronic, the potential for lead fracture only applies to Sprint Fidelis Leads manufactured between September, 2004 and October 15, 2007. To find out if your defibrillator lead is recalled, contact one of the experienced products liability attorneys at (800) 279-6386.

If you have a recalled Medtronic Sprint Fidelis lead, you may have legal claims against Medtronic for the damages you have suffered. Contacting an experienced products liability attorney is vital to your recovery in a recalled lead claim. At Goldenberg & Johnson, we take your health seriously; if you would like to speak to an evaluator about your potential recalled lead claim, please contact our office toll free at 1-800-279-6386.