The nation’s largest maker of implanted heart devices, Medtronic, said Sunday that it is urging doctors to stop using a crucial component because it is prone to a defect that has apparently been linked to five deaths and has malfunctioned in hundreds of patients.
The faulty component is an electrical “lead,” or a wire that connects the heart to a defibrillator, a device that shocks faltering hearts back into normal rhythm. The company is urging all of the roughly 235,000 patients with the lead, known as the Sprint Fidelis, to see their doctors to make sure it has not developed a fracture that can cause the device to misread heart-rhythm data.
Such a malfunction can cause the device to either deliver an unnecessary electrical jolt or fail to provide a life-saving one to a patient in need. In most cases, the defibrillators can be reprogrammed without surgery to minimize the likelihood of faulty shocks.
Replacing leads on a heart device like a defibrillator is considered by experts to be far more dangerous than replacing the device itself. As a result, doctors said that patients are better off leaving the lead in place except in those instances where it has ceased to function.
Medtronic estimated that about 2.3 percent of patients with the Fidelis lead, or between 4,000 to 5,000 people, will experience a lead fracture within 30 months of implantation. Those patients will need to have the lead replaced, experts said. Read more here