A Product Advisory is a voluntary letter issued to inform physicians of an anomalous device behavior identified by Boston Scientific's Quality System. A Product Advisory is issued when there is a material elevation in risk to patient safety, potential for compromised lifesaving therapy, or when Boston Scientific can provide meaningful guidance to improve patient outcomes or device performance.
For additional information on weakened header bonds for specific pulse generators select the following product links; TELIGEN VR, TELIGEN DR and COGNIS. Refer to the malfunction pattern description reference list where Pattern 1, Subpectoral Implant, 2009 is related to subpectoral implants and pattern 116, Header is related to subcutaneous implants as published in the Q1 2010 CRM Product Performance Report.
