St. Jude Defibrillator May Still be Problematic

A new study says that the changes St. Jude Medical Inc. made to its heart defibrillator leads may not solve the problem of insulation defects that could possibly lead the device to fail and cause patient death.

The study by cardiologist Robert Hauser of the Minneapolis Heart Institute found that insulation issues with St. Jude’s Riata ST Optim and its newer Durata ICD led some devices to fail, according to Reuters. The updated leads are coated with a material expected to reduce the possibility of insulation abrasions.

“The results of this study suggest that Optim, a proprietary copolymer of silicone and polyurethane, does not prevent critical insulation failures in Riata ST Optim and Durata leads that are caused by friction with the can or another device," Hauser told Reuters.

Hauser also said the failures occurred in leads that were implanted for four years or less, according to Reuters. He concluded additional studies are needed to determine the incidence of these failures and the clinical implications they may have.

If you or a loved one has been harmed by an unsafe medical device, contact Sokolove Law for a free legal consultation and to find out if a product liability lawsuit may be able to help you. For legal help, call (800) 581-6358.

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