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Congress plans to examine defibrillator wire safety review process |
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Tuesday, 23 October 2007 |
Congress has sent a letter to the Food and Drug Administration stating that it will investigate the agency’s safety review process for defibrillator lead wires. The letter stated that the review was prompted by the recent Medtronic defibrillator recall of the company’s Sprint Fidelis leads, which were pulled off the market last week.
Medtronic recalled the Sprint Fidelis leads after they were linked to at least 5 deaths and more than 1,600 malfunctions or injuries. According to the company, the lead wires are more than twice as likely to fracture as other Medtronic defibrillator leads. When this occurs, a defibrillator can fail to work in the event of a heart attack, or can send painful, unnecessary jolts of electricity to a patient’s heart.
Rep. Henry Waxman, chairman of a congressional oversight committee, says that the FDA needs to explain why the agency doesn’t give the same kind of scrutiny to reviewing defibrillator lead wires as it does to the devices themselves. Some experts believe that the Sprint Fidelis leads—which were the thinnest lead wires ever made by Medtronic—may not have been durable enough to be safely used.
Several of the patients who were injured after using a defibrillator with one of the recalled lead wires have filed lawsuits against Medtronic. These lawsuits have alleged that the company marketed the Sprint Fidelis leads despite the fact that they were aware of the risk for injury from defibrillator wire problems that they posed. |