On October 15, 2007, Medtronic, Inc. recalled its Sprint Fidelis Defibrillator Leads manufactured from September 2004 through October 15, 2007, model numbers 6930, 6931, 6948, and 6949. The leads are thin wires which connect the implantable defibrillator directly to heart. When the leads break or fracture, they can cause massive, repetitive shocks to the patient' heart.
Deaths and Complications from Medtronic Leads
Medtronic representatives admit 4,000 to 5,000 patients with the recalled leads will experience lead fracture within 30 months of implantation. According to the Food And Drug Administration (FDA), the agency responsible for regulating the safety of various products, deaths and major complications have occurred from these leads. As of October 15, 2007, at least five people died from complications associated with the leads. The recalled leads were implanted in over 200,000 patients since 2004.
Medtronic Recall Creates Difficult Decisions for Patients and Doctors
When working properly, defibrillators provide potentially life-saving shocks if the patient' heart goes out of rhythm. As discussed by Lawrence Altman of the New York Times, learning that a lead is defective (after testing) can create agonizing decisions for patients and doctors. Removal poses a risk of damage to the heart and veins. If the faulty lead is left, the patient is at risk of sustaining agonizing and potentially deadly shocks or the device could simply fail to deliver a life saving shock at a time when it is most needed. Patients with a defective lead should consult their doctor immediately to discuss their options.
For more recall information on Medtronic Sprint Fidelis Defibrillator Leads, please refer to the FDA' website at www.fda.gov/.
When to Contact a Product Liability Attorney over Recalled Medtronic Lead
In the event you or someone you know has a recalled Medtronic Sprint Fidelis Defibrilator Lead, make sure to contact an experienced product liability attorney who can assist in obtaining compensation regardless of whether the device has malfunctioned or has been removed.