The failure rate of Medtronic’s Sprint Fidelis leads may be much higher than previous estimates, according to a new report by Robert Hauser and David Hayes in HeartRhythm. The two investigators (Hauser was the first to spot the problems with the Medtronic leads) looked at the rate of lead failure among patients who received the leads at the Mayo Clinic and the Minneapolis Heart Institute. Lead failure was significantly higher in the group that received the Sprint Fidelis leads (3.75%/year vs 0.58%).
Three year lead survival was 87.9% for the Sprint Fidelis vs 98.5% for other leads. Lead failures caused inapprorpiate shocks in 36 of 72 patients, according to Hauser and Hayes.
In an article by Thomas Burton in the Wall Street Journal, Medtronic reports a much better record for its leads: “Medtronic says that its ‘all cause’ failure rate for the Sprint Fidelis at three years is 4.6%, meaning that 95.4% of the devices would be working at that point.”

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