Medtronic Heart Device Recall

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.
The Fidelis wire has been used with Medtronic defibrillators since 2004 and most patients who received Medtronic defibrillators since then have received the Fidelis wire.