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Editor: Marc Jay Bern
Profession: Defective Medical Device Lawyer

Category: About Sprint Fidelis Defibrillator Lead Lines

The defibrillator leads taken off the market last week by Medtronic, may pose a significantly higher risk of fracture in young adults and children. The devices were popular in part due to their small diameter.

While children make up a small share of the patients who receive the implanted devices, the devices tend to come under greater stress in active people such as kids, adolescents and young children.

On Monday, Medtronic announced a voluntary recall of their Sprint Fidelis leads due to the risk of fractures that could cause the device to dispatch erroneous jolts of electricity to the patient.

Of the 268,000 Sprint Fidelis leads implanted, 2,085 of them were in patients under the age of 21. Approximately 235,000 patients still have leads. Medtronic confirmed that the lead fractures may have contributed to five deaths. However, the ages of the deceased patients have not been made public as of yet.

Preliminary data from physicians at 32 institutions who specialize in treating pediatric patients and adults with congenital heart disease showed a fracture rate of 6.7% among 569 patients with Sprint Fidelis leads over 30 months. The "vast majority" of the patients are likely to be under the age of 21, given the physicians involved, says Wayne H. Franklin, an associate professor at Northwestern University's Feinberg School of Medicine, who gathered the physician reports.

Medtronic has reported a lower failure rate, 2.3% after 30 months, for all patients implanted with one particular Sprint Fidelis model. For that same model, Dr. Franklin saw a fracture rate of 4.9% among 304 patients in his survey. The real difference may be slightly greater, because the failure rate from Medtronic includes more than just fractures.