Correction on St. Jude Medical’s Riata lead
This article was originally published in The Gray Sheet
Executive Summary
While concerns about the firm's Riata defibrillator lead causing perforations have been raised in journal articles and FDA adverse event reports, the firm has never issued a physician notification or alert for the device, as was erroneously reported by "The Gray Sheet" (1Oct. 13, 2008, p. 15). At a Heart Rhythm Society meeting in May, St. Jude presented an analysis from four prospective studies showing very low lead-related complication rates. The firm continues to emphasize the safety and reliability of the device