Medtronic admitted that at least thirteen people might have died in correlation with a heart device, known as Sprint Fidelis, that it recalled in 2007 but was still in widespread use. This number includes four patients who died while surgeons were attempting to remove the product and is the first new data to reflect fatalities since the device was first recalled; the other nine deaths may be tied to the device’s failure to work properly. The Food and Drug Administration (FDA) has also said it received about 2,200 reports of serious injuries related to the device. The heart device is a thin electrical cable that connects an implanted defibrillator to the patient’s heart. It was recalled due to fractures in the cable that may cause the defibrillator to fire for no reason or fail to deliver a life saving shock to a patient’s irregular beating heart. Presently about 150,000 patients still have the Sprint Fidelis leads in their bodies.
A previously disclosed Food and Drug Administration (FDA) report shows Medtronic began receiving reports about the problem in 2004, three years before they declared a recall; they even conducted their own internal investigations. This report is based on a visit by regulators to the Medtronic facility soon after the device was taken off the market, where officials interviewed executives and reviewed records. The company also changed their manufacturing process in the months leading up to taking the device off the market. A top Medtronic official, however, claims this “acute” change had nothing to do with the recall and even at the time of the recall, internal data did not suggest the device was fracturing at higher rates than other company leads.
By 2006, it is believed Medtronic knew there was a problem. The timeline regarding exactly when Medtronic knew about the problems with Sprint Fidelis could be a significant factor if patient lawsuits begin again. The Supreme Court recently agreed that patients may not sue device manufacturers whose products were approved by the FDA, however, new legislation introduced by Democrats in Congress may nullify this decision.