Sprint Fidelis Lead Recall 6930 Medtronic Lawsuit

As of October 2007, Medtronic was aware of at least 665 chronic fractures in returned Sprint Fidelis leads. The majority of these fractures (approximately 90%) have occurred in the anode or cathode conductors. The Medtronic Sprint Fidelis 6930 lead was included in the 2007 recall. There seems to be evidence that Medtronic has knowledge their Sprint Fidelis leads survival rate was unacceptable when compared to industry failure rates. When a lead breaks, or “fractures”, the lead may send false signals which can cause the defibrillator to deliver inappropriate shocks or in the alternative shocks may not be delivered when required. In the latest patient letter from May 2008, Medtronic continues to maintain that routine monitoring is the preferred option for patients rather than lead removal due to the risks involved with extraction of the lead.

Medtronic’s Sprint Fidelis leads were introduced in 2004 as a replacement for the Sprint Quattro Secure Lead Model 6947 (referred to as “Quattro leads”). The Sprint Fidelis leads were marketed as being smaller and more effective for patients with implantable cardiac defibrillators (ICDs).

There is currently no test to predict which leads will fracture and the FDA is encouraging patients to seek follow-up care with their doctor to discuss options. It is not recommended that patients automatically have a fractured lead removed due to the risks involved with a surgical removal.

The FDA and Medtronic have recommended that Physicians balance the risks and benefits of either leaving the lead implanted along with careful monitoring or implanting a different lead model. Extraction of leads involves serious risks to the patient. Some of the reported complications of lead removal include: lead breakage and migration; avulsion of veins, myocardium of the tricuspid valve; tears of the myocardium or veins; hemothorax, tamponade, perforation, emergency cardiothoracic surgery, pulmonary emboli, and death.

There are two main locations on the recalled Medtronic leads where fractures have occurred:

1. The distal portion of the lead which affects the anode (ring electrode) and;
2. Near the anchoring sleeve tie-down, predominantly affecting the cathode (helix tip electrode), and occasionally the high voltage conductor.

On October 15, 2007, due to reports of at least five patients deaths linked to their defibrillator leads, Medtronic informed patients with Sprint Fidelis lead Model 6930 that their defibrillation lead was recalled. The Medtronic recall also affected patients with lead Models 6931, 6948 and 6949. Patients can identify which Medtronic lead they have by referring to their Patient ID card (wallet card) which will contain the model of their implanted lead. If a patient is unsure about which lead they have implanted they should consult with their physician.

A total of 268,000 Sprint Fidelis leads were implanted worldwide, with 172,000 leads implanted in the United States. As of January 2007, approximately 236 Medtronic Sprint Fidelis Model 6930 leads had been implanted. Implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) are used to treat abnormal heart rhythms in patients which can cause the heart to suddenly stop. ICDs and CRT-Ds shock the heart back into normal rhythm by delivering a pulse of energy through an electronic wire (lead) that is connected to the heart.

ICDs consist of a generator, a processor and a lead. The lead works to conduct the electrical impulses between the heart and the ICD. Low voltage pacing therapy to treat slow heart rhythms is provided through pace-sense electrodes. High voltage defibrillation shocks are delivered through high voltage conductors.