The higher than expected early failure rate of the Sprint Fidelis implantable cardioverter defibrillator lead (model 6949, Medtronic, Inc.).

摘要

In the July 2007 print edition (online April 2007) of the Journal, Hauser et al reported the higher than expected early failure rate of the Sprint Fidelis implantable cardio-verter defibrillator lead (model 6949, Medtronic, Inc.) and recommended limiting its use until the issue was resolved.Over the last two and a half years, 180 Sprint Fidelis model 6931 (single coil) leads have been implanted and 5 have failed after an average of 16 months (range 13-19 months). In one case the lead malfunction was detected on routine device interrogation (impedance rise and electrical noise on the pace/sense channel).