Medtronics Sprint Fidelis defibrillator leads continue to be a source of trouble for the medical-device maker and patients who have the implants despite removal of the product from the market in October 2007.
On Friday, the company sent a letter to physicians raising the number of estimated deaths in conjunction with the leads from five to 13. The leads were recalled 17 months ago after a review determined that the devices sometimes delivered inappropriate shocks to patients hearts. Patients who had already received the implants were advised by the devicemaker not to remove them, as the risk of surgery may outweigh the risk of the device malfunctioning.
About 268,000 patients worldwide have received the Sprint Fidelis defibrillator lead implants. The Food and Drug Administration has received reports of 107 deaths suspected to be the result of lead malfunctions. Medtronic officials reviewed 89 of those reports and determined that 13 deaths may have resulted from problems with the device, according to the letter sent to physicians. Minneapolis-based Medtronic said four of those deaths could be traced back to surgery to remove the leads. The correspondence came two days after a U.S. District Court judge in Minnesota dismissed a class-action lawsuit filed against the company by shareholders who accused Medtronic of suppressing information about the defective leads.