Medtronic Inc.’s stated failure rate for the recalled Sprint Fidelis defibrillator lead has been disputed by some leading hospitals. According to a report in The Wall Street Journal, those hospitals – including the University of Rochester in New York state, the Minneapolis Heart Institute, the Mayo Clinic and the University of Ottawa – say the real fracture rate for the Sprint Fidelis is as much as two times greater that what Medtronic has publicly disclosed.
A lead is a wire that connects an implantable defibrillator to the heart. If a lead breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart.
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. When the Sprint Fidelis recall was issued, 268,000 defective Sprint Fidelis leads had been implanted worldwide, and about 235,000 people still had these leads in their chests.
In March 2009, we reported that Medtronic sent a letter to doctors informing them that the faulty wires were a “possible or likely contributing factor” in as many as 13 deaths. Four of the deaths occurred when doctors tried to remove defective Sprint Fidelis leads from patients. Now, The Wall Street Journal is reporting that according to the Food & Drug Administration (FDA) database, 12 additional deaths allegedly linked to the Sprint Fidelis have been reported to the agency since last March
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 a report from the University of Rochester published in the January issue of the American Journal of Cardiology said the three-year survival rate of 426 Medtronic leads inserted in patients there was 90.8%, meaning 9.2% failed. A report from the Mayo Clinic published last February in the journal HeartRhythm said the estimated rate of failure among 848 leads implanted there after three years of use was 12.1%.
Another HeartRhythm study published in October 2008 by the University of Ottawa found the risk of a Sprint Fidelis fracture “increased significantly with time.” In November, a separate Mayo Clinic study showed the failure rate for Sprint Fidelis leads after two years was 20.4% in patients younger than 50, while the rate in older patients was only 3.5%.
Replacing a defibrillator lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis leads were told to leave the defective components in place unless they fracture. According to a study conducted at the Minneapolis Heart Institute which involved a search of the FDA database, extractions from 1995 through 2008 led to 57 reported deaths and 48 serious cardiovascular injuries. The total number of extractions wasn’t contained in the data., The Wall Street Journal said.
