Guidant reports more deaths
This article was originally published in The Gray Sheet
Executive Summary
A total of seven deaths have been linked to the shorting-out problem in Guidant's Prizm 2 DR, Contak Renewal, and Renewal 2 devices, including three since the firm's last update on the defect on Sept. 12, the firm reports Dec. 13. To date, Guidant has filed 31 MDR reports with FDA related to Prizm 2, two of which involved patient deaths, and 29 reports related to the Contak Renewal and Renewal 2, including five involving deaths. Guidant posts updated MDR information on its website in quarterly product performance reports (1"The Gray Sheet" Nov. 14, 2005, p. 5)...
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