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Medtronic Sprint Fidelis Risk Grows Over Time

Feb 24, 2009 | Parker Waichman Alonso LLP

A new study has found that Medtronic's Sprint Fidelis defibrillator leads are still putting patients at risk.  The Sprint Fidelis leads were removed from the market in October 2007 because of their higher-than-normal fracture rate.

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.

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.  

According to a report in The Wall Street Journal, the researchers who first spotted problems with Sprint Fidelis leads have found that the risk of a fracture increases as the device ages.  According to cardiologists at the Minneapolis Heart Institute, out of  3,037 patients implanted with defibrillator leads of varying models, a total of 94 leads failed. Seventy-two of the failures were Sprint Fidelis leads, out of 848 Sprint Fidelis leads implanted, The Wall Street Journal said.

The 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.

"The hazard of the Sprint Fidelis lead is increasing, while the failure rate of other defibrillator leads are low and stable,” the study authors wrote.

These findings mean 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.

Not surprisingly, the Sprint Fidelis defects spawned scores of personal injury lawsuits.  Unfortunately, as we reported earlier this month, the future of those lawsuits was placed in doubt 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.