What are the risks associated with the recalled leads?
Currently, there are over 235,000 defibrillator patients at risk. The Medtronic Sprint Fidelis defibrillator leads were approved in September 2004, and it is estimated that approximately 235,000 leads have been implanted since their launch. Medtronic estimated that about 2.3 percent of patients with the Fidelis lead, or 4,000 to 5,000 people, would experience a lead fracture within 30 months of implantation. However, this number will likely be higher as the risk of fracture may increase over time.
