Guidant Divulges More Detail On CRM Devices, Forms New Advisory Team
This article was originally published in The Gray Sheet
Executive Summary
Guidant is continuing its efforts to increase public access to device performance data by publishing quarterly reports detailing the number of extraordinary failures of cardiac rhythm management pulse generators and leads
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Guidant reports more deaths
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)...
Guidant reports more deaths
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)...
Guidant Posts CRM Performance Data As Stakeholders Discuss Recall Notices
Guidant is providing its 2005 Product Performance Report on its website as part of an effort to improve patient and physician access to device performance information, following a recent string of safety alerts