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Research In Brief

This article was originally published in The Gray Sheet

Executive Summary

Defibrillator lead failure survey: Canadian registry data provides the most accurate estimate of the "real" failure rate of Medtronic's Sprint Fidelis implantable cardioverter defibrillator leads, according to an editorial by Andrew E. Epstein and G. Neal Kay, University of Alabama at Birmingham, in the May issue of HeartRhythm. The editorial accompanies results of an independent survey of all 23 ICD-implanting centers in Canada conducted in the fall of 2007. The survey found that the Sprint Fidelis failure rate was 1.29% over 21 months, with lead failure reported in 80 of 6,181 patients. The Canadian data "present an experience that likely accurately reflects the real failure rate, as all but two Canadian implant centers reported to this registry," Epstein and Kay explain. Medtronic suspended distribution of Sprint Fidelis leads in October 2007 in response to data showing higher than anticipated fracture rates (2.3% over 30 months) and reports of five deaths (1"The Gray Sheet" Oct. 22, 2007, p. 3)
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