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Medtronic Inc from Monday 15th October 2007 has suspended sales of a component used in its implantable devices to treat abnormal heart rhythms, after the equipment may have contributed to five patient deaths. Medtronic ceased sales of the Sprint Fidelis line of "leads" which are wires that link the heart to an implantable cardioverter defibrillator (ICD), a life-saving device that can shock a racing heartbeat back to normal rhythm.
Recalls of the leads are particularly problematic because the wires, which are threaded through blood vessels, are difficult to remove. Medtronic have advised that the leads have a "small increased risk of fracture" and recommended that patients not have them removed due to the possibility of injury during any replacement, advice which is supported by the U.S. Food and Drug Administration. Instead, patients should see their doctors to have their ICDs reprogrammed to better monitor for the potential of a lead to fracture. About 268,000 of the leads have been implanted worldwide.
The Sprint Fidelis leads were developed as a thinner, more flexible alternative to the company's older model Sprint Quattro leads. Medtronic has identified five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor. Medtronic is contacting some 13,000 physicians worldwide to advise patients on their options. It said lead fractures may cause "inappropriate shocks and/or loss of output."
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