Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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

You may also be interested in...



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

Related Content

UsernamePublicRestriction

Register

MT022896

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel