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Boston Scientific ICD alert

This article was originally published in The Gray Sheet

Executive Summary

Patients with Cognis cardiac resynchronization therapy defibrillators (CRT-Ds) and Teligen implantable cardioverter defibrillators (ICDs), along with existing right ventricular lead problems, may experience unnecessary shocks if the devices' respiratory sensors are programmed "on," the firm tells physicians in a March 23 1letter. The company recommends that the optional respiratory monitoring feature be turned "off." About 8,000 devices are affected worldwide (2,000 in the U.S.), and no patient deaths have been reported. Cognis and Teligen, approved in May 2008, are among the first in-house defibrillators launched since Boston Scientific's 2006 acquisition of Guidant (2"The Gray Sheet" May 19, 2008, In Brief)
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