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Implantable cardioverter defibrillators (ICDs) stop life-threatening arrhythmias and are the most successful treatment for ventricular fibrillation, which is the major cause of sudden cardiac arrest. Both the ICD and the leads are expected to eventually cease functioning as a result of normal use and wear and tear. A malfunction of the device occurs when it fails to meet specifications and perform as intended. Infrequently, a lead may break (or fracture) and send false signals that cause inappropriate shocks or fail to deliver pacing or shocks.
Recently, Medtronic voluntarily suspended distribution of Sprint Fidelis defibrillation leads. Among the 268,000 Sprint Fidelis leads implanted worldwide, five patient deaths have been identified that…