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Medtronic Fidelis Fracture Rates Accelerate Over Time, Study Finds

This article was originally published in The Gray Sheet

Executive Summary

Fracture rates with Medtronic's Sprint Fidelis implantable cardioverter defibrillator leads are increasing over time, according to new research published online Feb. 23 by the journal HeartRhythm

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A 10-year retrospective study from the Cleveland Clinic shows that implantable cardioverter defibrillator leads subject to recalls can be extracted with the same safety and efficacy as non-recalled ICD leads. Another study, published in the same issue of Heart Rhythm, found that younger age and female sex are independent predictors of failure for St. Jude’s Riata lead.

Thirteen Deaths Now Blamed On Medtronic’s Recalled Fidelis ICD Leads

Medtronic has added eight patient deaths to the list of those linked to a failure of its recalled Sprint Fidelis implantable cardioverter defibrillator leads, but says the latest adverse event report data does not identify any new or unexpected trends

Thirteen Deaths Now Blamed On Medtronic’s Recalled Fidelis ICD Leads

Medtronic has added eight patient deaths to the list of those linked to a failure of its recalled Sprint Fidelis implantable cardioverter defibrillator leads, but says the latest adverse event report data does not identify any new or unexpected trends

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