It seems there is some controversy brewing about the true failure rate for Medtronic Inc.’s recalled Sprint Fidelis defibrillator lead. According to The Wall Street Journal, Medtronic says its own research shows the Sprint Fidelis leads survive for three years at least 95.4% of the time, for a failure rate of 4.6%. But data from some leading hospitals indicates the true rate could be much higher.
Medtronic Inc.’s Sprint Fidelis lead was removed from the market in October 2007, following reports of 5 deaths due to lead fractures. Before the recall, Sprint Fidelis leads had been implanted with 90% of Medtronic’s defibrillators. (more…)
