Medtronic Sprint Fidelis Defibrillator Lead Patients Face UncertaintyNov 16, 2007 | Parker Waichman LLP
The Medtronic Sprint Fidelis Defibrillator Lead wire, which was recalled last month for a higher –than-normal fracture rate, continues to endanger thousands of people. Because it is dangerous to replace a defibrillator lead, patients who received a defective Sprint Fidelis Lead must live with the knowledge that their Medtronic Sprint Fidelis Defibrillator Lead could one day fracture, leaving them at risk for serious injury and even death.
Medtronic suspended sales of the Sprint Fidelis Lead after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it 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 are being told to leave the defective components in place unless they fracture.
But it turns out that Medtronic may have been able to spare some of these patients the anxiety brought on by the Sprint Fidelis Defibrillator recall. Even before it went to market, Medtronic started a study of the Sprint Fidelis Lead. According to a report in the Wall Street Journal, that study revealed that from late 2004 through February 2007, there had been more than 200 fractures reported for Sprint Fidelis Leads. That was compared to 64 for Medtronic’s other defibrillator leads. But sources have told the Wall Street Journal that at a July 19 internal meeting to discuss the problem, Medtronic’s management still insisted that the number of Sprint Fidelis Lead fractures was not “statistically significant”.
Earlier this year, the Minneapolis Heart Institute decided to conduct a data analysis of Sprint Fidelis Lead fracture reports from hospital databases around the country. The researchers found that the thinner Sprint Fidelis lead had a higher chance of fracturing than an earlier Medtronic defibrillator lead. As a result of those findings, the Minneapolis Heart Institute quit using the Sprint Fidelis lead, and the study authors informed the FDA that the defective Sprint Fidelis Lead was “significantly less reliable” than its predecessor. While Medtronic did write a letter to doctors in March 2007 warning them of the Sprint Fidelis lead’s possible problems, the company maintained that the fractures were partly the result of the components not being properly implanted.
By October, however, Medtronic could no longer ignore reports that the Sprint Fidelis lead was fracturing at unusually high rates. By then, the company’s analysis had revealed that the defective Sprint Fidelis Leads had a 2.3% fracture rate within 30 months of implantation. Finally, unable to deny that such numbers were not “statistically significant,” Medtronic recalled its defective Sprint Fidelis Leads. But by that time, thousand of people had been implanted with these leads. Now, these unfortunate patients have no choice but to live with the knowledge that their Sprint Fidelis Lead could fracture at any time, placing them in mortal danger.