February 26, 2009

New study shows failure rate of Medtronic Sprint Fidelis Leads are significantly higher than previously known

More than 235,000 patients received a Medtronic Sprint Fidelis Lead, an electrical cable that connects a defibrillator to a patient’s heart. A Class 1 Recall was issued by the FDA on October 15, 2007, for Medtronic Sprint Fidelis Leads with model numbers 6930, 6931, 6948, and 6949 manufactured from September of 2004 through October 15, 2007.  Many patients with defibrillators using a Medtronic Sprint Fidelis Lead were being shocked unnecessarily or having their heart device fail to deliver a life-saving shock when needed due to a flaw in the device.  Doctors and patients faced a difficult choice in deciding what to do because undergoing surgery to remove the defective leads could pose serious risks. A new report published on Monday, February 23, 2009, by two prominent cardiac specialists published in the medical journal Heart Rhythm indicates the leads may be failing at a higher rate than previously known.  More troubling is the study also indicates that the failure rate might by increasing over time.  The new study found that the Medtronic Sprint Fidelis Lead was functioning in only 88% of patients studied three years after being implanted. Medtronic previously released contrasting data showing that the leads continued to work in about 95% of patients after a three-year period.


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