The Wall Street Journal (3/14, B5, Burton) reported that “Medtronic Inc. said the number of deaths in which its fractured defibrillator wires may have been a ‘possible or likely contributing factor’ has risen to 13.” The new number “is the company’s first update of its death estimate since the Sprint Fidelis, then the No. 1 such device in the world, was first recalled.”
When the company recalled the device in October 2007, it “cited five deaths…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,” the New York Times (3/14, B1, Meier) added on the front of its Business Day section. According to the Times, the “death statistics Medtronic released Friday underscore both the scope of the Sprint Fidelis problem and the difficult choices that doctors and patients face in deciding what to do about it. About 150,000 people in this country still have the Sprint Fidelis leads in their bodies.” The updated figures were “based on a review of available data by company officials and a panel of five outside physicians,” according to Medtronic. The panel “was particularly concerned with the four deaths related to surgical efforts to remove the lead,” and “appears to have concluded that the nine other deaths may have been tied to the device’s failure to function properly.”
Meanwhile, the AP (3/13, Perrone) reported that the “Food and Drug Administration has received 107 reports of patient deaths where the devices may have played a role. Most of those reports were not filed by physicians, Medtronic notes, but ‘by family members or attorneys with minimal supporting data.'”
Bloomberg News (3/14, Olmos) noted that the panel Medtronic cited “recommended against removing leads as a safety precaution only, without some evidence that the wires might be faulty.” Also, the “panel recommended that removal of faulty leads ‘be performed by a physician with extensive lead extraction experience,’ the company said.” Minnesota’s Star Tribune (3/14, Moore) also covered the story.
From the American Association for Justice news release.
