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Medtronic Suspends Marketing of Defibrillator Leads


Medtronic has voluntarily suspended distribution of its Sprint Fidelis defibrillator leads, because of fractures occurring in <1% of the approximate 268,000 of the leads implanted worldwide. Although a defibrillator lead that is slightly more prone to fracture may never break, when a lead does break, or "fracture," it may send false signals that cause inappropriate defibrillator shocks. It may also prevent therapies such as pacing or shocks from being delivered. This was the cause for the voluntary suspension of the leads.

The routine surgical removal of a fractured lead is not recommended, because removal carries risks. Instead, physicians are urged to weigh the risks and benefits of continued use of implanted leads and carefully monitor patients, or cap the lead so it is no longer usable, then implant a different model.

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