Sprint Fidelis leads: is the risk greater than feared?

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.”

Trackbacks

  1. […] NY Times: why is the ICD registry languishing? Published February 27, 2009 Uncategorized  In 2004 Medicare mandated the creation of a national ICD registry, which has been run since then by the ACC and HRS. Now, New York Times reporter Barry Meier, who has been instrumental in bringing to light ICD problems in the past, notes in a February 26 story that the ICD registry is languishing for lack of financial support from industry, that due to industry neglect, the registry has failed to identify new problems, such as the recent study showing a high rate of problems with the Sprint Fidelis leads.  […]

Speak Your Mind

*