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Medtronic Fidelis update

This article was originally published in The Gray Sheet

Executive Summary

Failure rate for Medtronic's Fidelis ICD lead is 4.8% (+2.1 or -3.6) at 39 months, according to data from the firm's System Longevity Study, and 3.5% (+0.6 or -0.6) according to data from its CareLink remote monitoring network, the company reports Aug. 29. Medtronic recalled the size 7 French lead in October 2007 when the System Longevity Study and CareLink network showed the 30-month failure rate was 2.3%. By contrast, the failure rate for Medtronic's Quattro lead is 0.9% (1"The Gray Sheet" Oct. 22, 2007, p. 3). Separately, on Sept. 4, FDA approved an update to the software Medtronic is using to track Fidelis lead fractures called the Lead Integrity Alert. The feature allows defibrillators to make an audible tone when it detects a possible lead fracture
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