Removing Sprint Fidelis Leads — A Difficult Choice
In 2007, the New York Times reported on the high failure rate of the Sprint Fidelis leads used by Medtronic’s implantable defibrillators and the dangers that they posed to unwitting patients. Not only could fractured leads cause the defibrillators to randomly emit powerful, painful electrical shocks to a patient’s heart, but they could also interfere with the defibrillators’ ability to perform their life-saving functions.
Years after Sprint Fidelis leads were first sold, approximately 5% of the over-250,000 patients with the device have been affected by lead fracture or failure. But even patients implanted with working Sprint Fidelis leads must make a difficult decision: is it better to brave the risk of fracture and leave the potentially dangerous cables as they are, or better to have the cables removed through a risky surgical procedure?
Experts are divided on the issue. Some doctors believe that the risk of heart surgery is great enough to warrant a “wait and see” approach; others feel that proactive removal of the faulty defibrillator leads is the best choice. There are very real dangers associated with each option; thus far, several people have died due to malfunctioning Medtronic defibrillators, and at least 4 have died during surgery to remove the faulty leads.
Most doctors do agree, however, that patients who opt to remove implanted Sprint Fidelis leads should be very careful in choosing a hospital or surgeon to handle the procedure. Removing implanted medical devices can be extremely tricky, due to the ingrowth of tissue; in fact, certain hospitals specialize in such procedures. Patients who want to remove Sprint Fidelis leads should take care to select a hospital with significant experience in related procedures to minimize the risk of complication.
Taking Legal Action
At Williams Hart, we believe that heart patients should never have had to choose between living a life with a potentially dangerous implanted device and undergoing risky surgery to have the device removed. We believe that Medtronic, as the party at fault, ought to compensate patients and their families for the financial, emotional, and physical costs of their faulty product.
Unfortunately, although it agreed to pull its Sprint Fidelis leads from the market, Medtronic has been fighting hard to avoid any real consequences for its dangerous device. Instead, the company has attempted to shift responsibility onto the shoulders of the FDA, the agency that approved the device for sale.
If you or someone you love has been hurt by an implantable Medtronic defibrillator with Sprint Fidelis leads, Williams Hart may be able to help you hold Medtronic responsible for the faulty product they sold. Contact us at (800) 220-9341 for more information.