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Medtronic Halts Sales of Defibrillation Leads

Medtronic has voluntarily suspended distribution of its Sprint Fidelis family of defibrillation leads, because of potential lead fractures that may be implicated in at least five deaths. Lead fractures can lead to inappropriate shocks or, worse, failure to shock. The model numbers affected are 6930, 6931, 6948, and 6949. The leads are used in Medtronic's implantable cardioverter-defibrillators and its cardiac resynchronization therapy defibrillators. They are not used in its pacemakers.

The firm does not suggest that patients have the leads explanted, as the surgical risks outweigh the risks associated with lead fracture. It has set up a Web site with information for patients, physicians, and media. The suspension occurred not because of public outcry or excessive reports of adverse events, but because of statistical analysis by the company that showed the Fidelis leads have lower viability after 30 months than other Medtronic leads, by a factor that would become statistically significant over time. Medtronic deserves credit for being so proactive on this matter -- indeed, for taking the opposite stance of Guidant, which downplayed or ignored safety issues with its ICDs. Still, one wonders whether the confidence of the public, clinicians, and regulators in implantable defibrillation will be further harmed because of this. UPDATE: To no one's surprise, two lawsuits, in Minneapolis and Puerto Rico, have already been filed. UPDATE 2: FDA issued a statement agreeing with Medtronic's course of action. UPDATE 3: Echoing what the comment from Jack stated below, Public Citizen says Medtronic and FDA knew about the problem well before the recall, and Sen. Chuck Grassley wants some answers. UPDATE 4: The New York Times reports that, as a result of the Medtronic problem, FDA is looking into whether it should mandate more rigorous testing of certain heart-device components. UPDATE 5: On Oct. 22, Congress notified FDA that it is reviewing how rigorously the agency requires heart-device components to be tested. UPDATE 6: An investor has sued Medtronic, claiming the company made false and misleading statements about the leads when it told investors that the leads enjoyed "strong market acceptance."

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