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Medtronic Sprint Fidelis Defibrillator Lead Poses Greatest Danger to Young People

Oct 19, 2007 | Parker Waichman LLP

Defective Sprint Fidelis leads used with Medtronic implantable defibrillators could be far more dangerous for young people and pediatric patients.   What’s more, Medtronic, Inc. could be vastly understating the fracture rate of the Sprint Fidelis Defribrillator lead, as some studies have found that rate to be significantly higher than the 2.3% reported by Medtronic.

Earlier this week, Medtronic announced that it was suspending sales of the defective Sprint Fidelis lead, a thin wire that connects an implantable defibrillator to the heart.  The company said that the lead could fracture, causing the defibrillator to either send a massive, painful electrical shock to the heart; or prevent the defibrillator from emitting a necessary, lifesaving shock.   According to Medtronic’s own estimate, 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.   Those patients whose Sprint Fidelis lead fractures will require a dangerous surgical procedure to have the wire replaced. At least five deaths have been attributed to the defective Sprint Fidelis leads.

According to a recent article in the Wall Street Journal, since being introduced in 2004, Sprint Fidelis leads have been implanted in 268,000 patients.  Of those, 2,085 were in people under 21.  The Sprint Fidelis lead was considered a good choice for children, adolescents and young people because the thinness of the component made the wire easier to thread into tiny blood vessels.  But because children and young people are more active and their hearts beat faster than adults, defibrillator leads are more likely to fail in younger patients.

And the evidence does suggest that these patients could be at the highest risk for a Sprint Fidelis lead fracture.  According to the Wall Street Journal, preliminary data from physicians at 32 institutions indicated that the vast majority of people who experienced fractures of Sprint Fidelis leads were under the age of 21.  That survey is similar to Medtronic’s own findings released Monday.  According to the company, the rate of fracture for Sprint Fidelis leads 30 months after implantation was 3.8% for patients younger than 21.   The failure rate stated by Medtronic for the entire population was 2.3%.

But even the lower number could be off.   At least two independent studies cited by the Wall Street Journal show much higher rates of Sprint Fidelis fracture rates.  Data compiled by a researcher at Northwestern University’s Feinberg School of Medicine found that over 30 months, the fracture rate in 569 patients with the defective leads was a staggering 6.7%.  A second survey by the same researcher found that of 304 patients implanted with a particular Sprint Fidelis model, the fracture rate stood at 4.9%.  

Despite the dangers posed by the defective Sprint Fidelis lead, most doctors are telling patients to leave them in place if they haven’t fractured.  The procedure to replace a defibrillator lead is extremely invasive and dangerous.  The surgery can cause blood vessels and other tissue to tear and scar.  In fact, replacing a defibrillator lead is far riskier than replacing the defibrillator itself.


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