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Research In Brief

This article was originally published in The Gray Sheet

Executive Summary

Boston Scientific ICDs: A weakened bond between the header and the case of a Boston Scientific Cognis cardiac resynchronization therapy defibrillator (CRT-D) implanted subcutaneously led to noise and inappropriate therapy in an 84-year-old patient, an article to be published in the journal HeartRhythm indicates. William Maisel, M.D., of the Medical Device Safety Institute at Boston's Beth Israel Deaconess Medical Center, and co-authors write that, "although uncommon, device header abnormalities should be suspected in all patients with Cognis and Teligen ICDs who have unexplained noise observed by any lead channel." Boston Scientific issued a product advisory in December reporting that weakened header bonds may lead to inappropriate therapy in both devices when implanted in the subpectoral position, although the firm said it only knew of two reported cases. Boston Scientific responds that it has "implemented manufacturing process improvements to strengthen the header bond on these devices, allowing physicians to implant devices in either a subpectoral or subcutaneous position" and expects to transition to improved devices "by next month.
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