Medtronic has reported that at least 13 people have died in connection with a heart device that it recalled in 2007, but was still in widespread use. This includes four patients whose deaths were related to efforts by doctors to surgically remove the product. The new data reflect the first fatality update by Medtronic since October 2007, when it recalled the device — a thin electrical cable that connects an implanted defibrillator to a patient’s heart. The company cited five deaths when it recalled the product, saying fractures in the cable could cause a defibrillator to fail to deliver a lifesaving shock to an erratically beating heart, or to fire for no reason.
Separately, a previously-undisclosed report from the Food and Drug Administration indicates that Medtronic began receiving reports soon after the device reached the market in late 2004 that the cable, known as the Sprint Fidelis, was fracturing. The company also revised its manufacturing process in the months before withdrawing the Sprint Fidelis from the market, according to this report.
There are a number of lawsuits pending filed by patients. When Medtronic may have known the Sprint Fidelis posed safety problems, and how it responded to that information, will be significant factors in these cases. As previously reported, Congress is moving to nullify the U.S. Supreme Court decision last year regarding medical devices. About 150,000 people in this country still have the Sprint Fidelis leads in their bodies. In addition to the fatalities, the FDA has received about 2,200 reports of serious injuries related to the leads. Our firm has handled a number of these cases and have cases currently pending. If you need information on this subject, contact Leigh O’Dell who is in our Mass Torts Section, at Leigh.Odell@beasleyallen.com or at 800-898-2034.
Source: New York Times
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