Medtronic News

Two major producers of heart devices, responding to a report by a medical group critical of industry's oversight of product safety, said yesterday that they planned to broaden how they conducted such reviews.

In separate statements, the two companies, Medtronic Inc. and St. Jude Medical, said they planned several steps to heighten their scrutiny of device safety and reliability, like increasing the number of outside doctors who serve as consultants reviewing such issues.

Medtronic, Inc., today said it is voluntarily advising physicians about a potential battery shorting mechanism that may occur in a subset of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) models. In a letter to physicians, Medtronic reported that nine batteries (0.01 percent, or approximately 1 in 10,000) have experienced rapid battery depletion due to this shorting action. If shorting occurs, battery depletion can take place within a few hours to a few days, after which there is loss of device function. There are no reported patient injuries or deaths.

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