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Medtronic Defibrillator Leads - Sprint Fidelis

Medtronic Sprint Fidelis Defibrillator Leads

Sprint Fidelis Leads 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. ICDs and CRT-Ds are devices that protect patients when life-threatening heart rhythms occur. Defibrillators monitor heart rhythms. They deliver an electrical shock or rapid pacing to restore normal rhythm when life-threatening, irregular heartbeats are detected. These devices keep the heart from going too fast. They are surgically implanted for patients who are at risk of sudden cardiac arrest. Medtronic, Inc., is announcing that it is voluntarily suspending worldwide distribution of the Sprint Fidelis family of defibrillation leads. This includes four Sprint Fidelis Models: 6930, 6931, 6948, and 6949. FDA considers this removal action to be a medical device recall. Medtronic is advising physicians to stop implanting the leads and to return unused products to the firm. The devices are being recalled because of the potential for lead fractures. These electronic wires are prone to fracture in a small number of patients. This could cause the defibrillator to deliver unnecessary shock or to not operate at all. Some deaths and other serious injuries have been reported in which a fracture in a Sprint Fidelis lead may have been a possible or likely contributing factor.

Medtronic Defibrillator Leads Side Effects

  • death
  • electric shock
  • extreme chest pain

Medtronic Defibrillators History

Medtronic, Inc. first announcecd a recall of a defribillator product on April 16, 2004 after receiving reports of at least 4 deaths and 1 injury. The two models recalled were the Medtronic Micro Jewel II Model 7223Cx and the Medtronic GEM DR Model 7271. Medtronic cited a charging problem that could possibly lead the defribillator to deliver remedy to late or not at all to a patient in need.

Medtronic, Inc. and FDA advised healthcare professionals of a Class 1 recall on April 3, 2005 of the LIFEPAK 500 automated external defibrillator (AEDs). The AED may continue to display a "connect electrodes" message and may not analyze the patient's heart rhythm even when the electrodes are properly connected. Failure to analyze the patient's heart rhythm will inhibit defibrillation, if it is needed. This action affects 1,924 first-generation LIFEPAK 500 AEDs that were manufactured in 1997, which represents approximately 1 percent of LIFEPAK 500 AEDs currently in use worldwide. In April 25, 2005 - An additional 396 monophasic LIFEPAK 500 AEDs were included in a voluntary recall originally announced on February 25, 2005.

Metronic, Inc. announched on October 15, 2007 that is was halting sales of the Sprint Fidelis Leads. These electronic wires are prone to fracture in a small number of patients which can cause the defibrillator to deliver unnecessary shocks or not operate at all. Based on our initial review of reported adverse events, some deaths and major complications have occurred after the leads have fractured.