Serious problems have surfaced with the Medtronic Spring Fidelis brand of defibrillator lead, and thousands of people implanted with this device are considered at risk.
Because of failure reports, the U.S. Food and Drug Administration issued a recall and ordered Medtronic Spring Fidelis defibrillator leads off the market in 2007. However, some 250,000 of these leads had already been implanted. Over time, even the company estimates that some 2.3 per cent – or 4,000 to 5,000 people – will experience a device malfunction. If this happens, the heart could receive a false signal and either get an unnecessary jolt of electricity or fail to get a get a jolt needed to restore a stable heart rhythm.
It’s obvious from the number of reports of complications and lawsuits filed that these leads were not adequately tested before being put on the market. Because of this, the manufacturer may be held responsible for injuries or deaths that occurred as the result of the defective product.
If you or a loved one were implanted with a Medtronic Spring Fidelis defibrillator lead and later suffered serious heart failure, you have the right to file a lawsuit. An experienced Medtronic Spring Fidelis defibrillator lead attorney with Janet, Jenner & Suggs can review your situation and advise you. All consultations are free of charge.
Anyone implanted with a defibrillator between 2004 and 2007 should check with their doctor, or on the wallet card given to them at the time of the implantation, to determine what type of leads were used. If it was the Medronic Spring Fidelis, they should discuss the risk of lead fracture or failure with their doctor. While failures are rare, if they occur they can be fatal.
While there is no way to test whether a lead may be faulty, Medtronic and the FDA have recommended that Medtronic defibrillator patients discuss with their doctors having their defibrillator settings adjusted to increase the likelihood that a fracture can be detected.
The Sprint Fidelis leads that have been recalled have the model numbers 6949, 6948, 6931 and 6930. These will be on the patient’s wallet card or in medical files a doctor can access.
Defibrillator leads connect a patient’s mechanical heart defibrillator, which is usually implanted near the shoulder, to a patient’s heart. The lead’s thin wires are threaded through veins. When the defibrillator detects an unstable heart rhythm, it sends a jolt of electricity through the leads to the heart, to restore rhythms to normal.
While Medtronic has not disclosed the precise mechanism of how these Sprint Fidelis leads have failed, it appears that the defect is caused by the small diameter of the coil and conductors in the lead. Because of this, the lead is subject to stress damage both during and after the defibrillator is implanted. A lead fracture occurs when the conductor is critically overstressed. While only five deaths have been reported, many people are reporting repeated electrical shocks due to their lead having fractured.
If you or a loved one were implanted with a Medtronic defibrillator lead and suffered injuries as a result, you may have valuable legal rights. Please fill out our online form, or call us toll-free at 1-877-My-Advocates (1-877-692-3862) to discuss your case with one of our pharmaceutical injury lawyers today.