In October, Medtronic Inc., makers of a wide range of medical devices, issued a voluntary suspension of its Sprint Fidelis defibrillation leads due to an increasing rate of lead fractures.

Rob Clark, Medtronic senior director of public relations, says the decision was based on both a statistical trend in Sprint Fidelis viability and a problem with the design leading to a greater chance of fracture.

“We decided to remove the product or suspend distribution of the product because, while the performance of the Sprint Fidelis is not statistically different from another lead that we have on the market, the Quattro, the research suggests that it will be different over time. With that information, as well as the fact that the manifestation of these fractures can be inappropriate therapy delivery or inappropriate shocks to the patient, we determined that it was best to suspend the distribution of this product.”

Implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds) are used to treat abnormal heart rhythms that can cause the heart to stop suddenly. ICDs and CRT-Ds shock the heart back into normal rhythm by sending a pulse of energy through an electronic wire, or lead, that is connected to the heart.

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