Medtronic Inc. Ignored Sprint Fidelis Lead Problems for MonthsOct 19, 2007 | Parker Waichman LLP
Medtronic Inc. is facing serious questions about its handling of problems with its defective Sprint Fidelis leads, a component of implantable defibrillators. Medtronic had been receiving reports of Sprint Fidelis lead fractures for months, yet only decided to suspend sales of the components this week. Considering the injuries that can result from a lead fracture, and the dangerous operation patients must undergo to have a lead replaced, many patient advocates are bewildered that Medtronic allowed the defective Sprint Fidelis leads to stay on the market for so long.
Medtronic suspended sales of the Sprint Fidelis leads on Monday, 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.
When it suspended sales of the Sprint Fidelis lead, Medtronic estimated that about 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis lead will experience fracture within 30 months of having a defibrillator implanted. Apparently, it was a problem that the company had known about for months. Since it was introduced to the market in 2004, there have been 599 reports of lead fractures as of January 2007. And it seems as though the fracture problems became worse over time. In the first two months of 2006, there were 27 reports of the Sprint Fidelis lead fracturing. But in the first two months of 2007, there were 152 reports. And since January 10, 2007, there have been a staggering 1,030 reports of fractures.
What’s more, problems with the Sprint Fidelis lead had also been reported in at least one medical journal. The article, written by doctors at The Minneapolis Heart Institute was based on a study of the incidence of lead failures in the Sprint Fidelis models compared to the Sprint Quattro models, an earlier lead made by Medtronic. The researchers found that the thinner Sprint Fidelis lead had a higher chance of fracturing than the Sprint Quattro. As a result of those findings, the Minneapolis Heart Institute quit using the Sprint Fidelis lead, and the study authors informed the Food & Drug Administration 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.
On Tuesday, Charles Grassley, a prominent Republican Senator from Iowa, sent letters to Medtronic demanding a meeting with the company to discuss the handling of the Sprint Fidelis lead problems, and already several lawsuits have been filed against Medtronic because of the faulty lead. Why the defective Sprint Fidelis lead was not removed from the market in March, or even earlier, is a question that Medtronic is going to have to answer.