Medtronic Letter Links Sprint Fidelis Leads to 13 Deaths, Possibly MoreMar 16, 2009 | Parker Waichman LLP
Medtronic's Sprint Fidelis defibrillator leads have been implicated in at least 13 deaths and could be linked to scores of others. That's up from the five fatalities Medtronic reported when the Sprint Fidelis leads were first removed from the market in 2007.
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. Replacing a 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.
In a letter sent to doctors, Medtronic said that the faulty wires were a "possible or likely contributing factor" to the 13 deaths. Four of the deaths occurred when doctors tried to remove defective Sprint Fidelis leads from patients.
The company also said in the letter that it has received a total 107 reports claiming that the Sprint Fidelis lead "may have caused or contributed to a patient death." An independent doctor panel is currently reviewing 89 of those claims, the Medtronic letter said.
Medtronic suspended sales of its Sprint Fidelis leads in October 2007, after receiving reports of 5 fatalities linked to lead fractures. Before the recall, Sprint Fidelis leads had been implanted with 90% of Medtronic’s defibrillators. According to the Wall Street Journal, 268,000 defective Sprint Fidelis leads had been implanted worldwide, and about 235,000 people still had these leads in their chests when the recall was issued.
Not surprisingly, the Sprint Fidelis defects spawned scores of personal injury lawsuits. Unfortunately, the future of those lawsuits was placed in doubt last month when a federal judge in Minneapolis dismissed hundreds of them. In dismissing the claims, the judge cited a Supreme Court ruling issued last year that barred personal injury lawsuits against device makers when a device has been approved by the Food & Drug Administration.
Medtronic's Sprint Fidelis death update is just the latest disturbing news regarding this dangerous defibrillator wires. As we reported last month, a group of researchers from the Minneapolis Heart Institute had also concluded that the risk of a Sprint Fidelis lead fracturing increases as it ages. Their study, published in the journal HeartRythm, saw a Sprint Fidelis failure rate of 3.75% a year, compared with 0.58% among other models. At three years after implant, 87.9% of the Sprint Fidelis leads were working, compared with 98.5% for other models studied.
This means that the Sprint Fidelis lead is still putting thousands of patients at risk. According to The Wall Street Journal, it is estimated that about 150,000 Sprint Fidelis leads remain implanted in U.S. patients.