It has been reported that a widely used heart device, recalled approximately two years ago by Medtronic, may be failing in patients at a rate significantly higher than previously reported by the manufacturer. The Medtronic device, known as the Sprint Fidelis lead, is an electrical cable that connects an implanted defibrillator to a patient’s heart. The study showed that the device’s failure rate is increasing over time. More than 235,000 people received the Sprint Fidelis leads before they were recalled, and many of those patients still have them in place. The device’s flaw, which made it prone to fracturing, caused some defibrillators to deliver unnecessary shocks to a patient’s heart or to not give a potentially life-saving shock when needed.
The study found that the lead was still functioning in only 88 percent of the patients studied three years after being implanted. By contrast, data collected by Medtronic, using that three-year yardstick, indicated the lead continued to work in about 95 percent of patients. Considering that the device is supposed to be a life-saving device, the difference in the failure rate is troubling.
Medtronic, without providing any supporting information or specific criticism of the new study, released a statement saying that it believes the failure rate it calculated was accurate. The new study is based on data from 3,000 patients from two major hospitals, the Minneapolis Heart Institute and the Mayo Clinic. Medtronic has conceded that the device's lead failure may have been involved in five deaths. If the failure rate is higher, the rate of deaths can be expected to climb.
The study authors stated that “The hazard of the Sprint Fidelis lead is increasing, while the failure rate of other defibrillator leads are low and stable.” Doctors and patients face difficult choices in deciding what to do when a lead fractures, because surgery to remove the leads can pose significant risks, and some patients have died during lead removal procedures.
The Sprint Fidelis lead was the subject of hundreds of lawsuits since its recall. Last month, however, a federal judge in Minneapolis dismissed all of the lawsuits, citing a Supreme Court ruling last year that found federal law shielded makers of FDA approved medical devices from product liability lawsuits. Essentially, all medical device manufacturers with FDA approval of their products cannot be found liable for making a defective medical device. Virtual legal immunity from responsibility for negligence is something that no other industry has and medical experts believe that without accountability, profits might be placed before patient safety. Congress is considering a clarification of the law to overturn the Supreme Court decision, but until then, patients with defective medical devices have no recourse.
