Medical device manufacturer, Boston Scientific, has issued a field safety notice concerning COGNIS Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and TELIGEN Implantable Cardioverter-Defibrillators (ICDs) manufactured prior to December 2009. The affected model numbers are as follows:
Boston Scientific has identified a low voltage (LV) capacitor component that, in some devices, may experience diminished performance after two or more years of implant time. This can increase battery use and eventually trigger one or more Safety Architecture alerts, accompanied by patient-audible beeping. All cases reported to date have been detected by diagnostic tools within Boston Scientific's Safety Architecture before device function was compromised.
"Safety Architecture" refers to a set of diagnostic monitoring tools in COGNIS and TELIGEN designed to mitigate potential device performance and clinical risks. These tools periodically assess device performance, including battery voltage, power consumption, and charge time, and have proven effective in identifying instances of unexpected battery use (via programmer alert screens or replacement indicators) before therapy becomes unavailable.
A total of approximately 264,000 COGNIS and TELIGEN defibrillators have been distributed and implanted since May of 2008. However, a subset of ~38,500 devices (15% of the total) that were manufactured prior to December 2009 has experienced a higher number of LV capacitor malfunctions (approximately 0.67% or 1 in 150).
Boston Scientific advises that there are no additional clinical recommendations beyond the current standard of patient care and normal device monitoring, which are described in device labeling. In addition, the manufacturer recommends physicians to call technical services when investigating a Safety Architecture alert. Following a Safety Architecture alert or Explant indicator due to diminished low voltage capacitor performance, the normal 3-month replacement window may be shortened and increased current drain could deplete the battery and compromise therapy/telemetry. Technical services can help estimate how much time is available to replace the device, should a low voltage alert or Explant indicator occur.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 30 August 2013