Concern Citizens Want defective lead wires off the market
Medtronic Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, said its profits have slipped 2% as a result of last month’s Sprint Fidelis recall. To make matters worse for the company, many are now asking if Medtronic acted quickly enough to get its faulty Sprint Fidelis Lead wires off the market.
Medtronic suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads are being told to leave the defective components in place unless they fracture.
Minneapolis Heart Institute conducted a data analysis of Sprint Fidelis Lead
Earlier this year, the Minneapolis Heart Institute conducted a data analysis of Sprint Fidelis Lead fracture reports from hospital databases around the country. The researchers found that the thinner Sprint Fidelis lead had a higher chance of fracturing than an earlier Medtronic defibrillator lead. As a result of those findings, the Minneapolis Heart Institute quit using the Sprint Fidelis lead, and the study authors informed the FDA that the defective Sprint Fidelis Lead was “significantly less reliable” than its predecessor. While Medtronic did write a letter to doctors in March 2007 warning them of the Sprint Fidelis Lead’s possible problems, the company maintained that the fractures were partly the result of the components not being properly implanted.
Some Medtronic critics have argued that Medtronic should have done more back in March. Dr. Sidney Wolfe, from the consumer advocacy group Public Citizen, is one of them. Some 1,194 associated injuries had been reported — up from 296 injuries reported in the first 10 months of 2006, according to a letter Wolfe wrote to the Food & Drug Administration. “Why did the FDA, aware of the rapidly mounting number of injury reports, not force the company to recall defibrillators not yet implanted in the early part of this year?” he wrote.
Medtronic maintains that it acted properly
For its part, Medtronic maintains that it acted properly, and others fault the FDA for not leaning on the company to do more in March 2007. Dr. Robert Hauser told Minneapolis Public Radio that when Medtronic sent a letter to physicians stating they ‘may’ have a problem, the FDA had a responsibility to act. “In retrospect, what might’ve been done was for the FDA to say simply, ‘Look, if you think you have a problem, why don’t you stop implanting until you figure out what the problem is, ’” Hauser said.
At any rate, it is now Medtronic that will deal with the fallout from the Sprint Fidelis Lead recall. The recall hurt revenue in Medtronic’s Cardiac Rhythm Disease Management unit by $130 million, and it also absorbed $31 million in costs to write off the Sprint Fidelis leads recalled during the quarter. Last month, Medtronic had predicted a $150 million to $250 million loss of second-quarter revenue and inventory write-off costs of $15 million to $20 million.