Yesterday, Medtronic, the world’s largest maker of implanted heart defibrillators, announced that it was urging doctors to stop using an electrical wire known as Sprint Fidelis, which connects the heart to a defibrillator. A defibrillator is a device which shocks the heart back into normal rhythm should it falter. The wire is prone to a defect that has resulted in malfunctions in hundreds of patients and may have contributed to five deaths.
There are an estimated 235,000 patients with the Fidelis. Such a malfunction can cause the device to either deliver an unnecessary electrical jolt or fail to provide a life saving jolt to a patient in need. According to Medtronic, in most cases, the devices can be reprogrammed without surgery to minimize the problem.
Medtronic estimated that approximately 2.3% of patients with the Fidelis wire, or four to five thousand people, will experience a fracture within 30 months of the implantation. These patients will require a delicate surgical procedure to replace the wire according to physicians. Replacing the wire is considered to be far more dangerous than replacing the device itself. As a result, physicians advise that patients are better off leaving the wire in place except in those instances where it has stopped functioning properly.



