TELIGEN implantable cardioverter defibrillators (ICD) and COGNIS cardiac resynchronisation therapy devices (CRT-D) 를 위한 안전성 경고 / 현장 안전성 서한

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

Risk of loss of therapy due to rapid battery depletion. Additional serial numbers of devices are affected since the manufacturer’s original notification in August 2013.In August 2013 Boston Scientific notified users about a subset of COGNIS™ CRT-Ds and TELIGEN™ ICDs that had experienced an increased rate of premature battery depletion due to a problem with a low voltage (LV) capacitor. The manufacturer has now identified a second subset of devices from subsequent clinical experience and analysis, which is expected to be affected by the same capacitor issue. This adds an additional 885 UK patients to the previous total of approximately 1,000 UK patients identified in August 2013.With this FSN the manufacturer has also notified pacing clinics about the recent introduction of updated Safety Architecture software that will improve early detection of diminished LV capacitor performance. In particular this software enhances detection rates for ICDs later in their device life, and provides a new alert indicator on the programmer screen and the LATITUDETM remote patient monitoring system (if used).The manufacturer has confirmed that the current prevalence of failures within the original advisory population has risen from 0.67% in August 2013 to 2% to date, with the newly identified devices expected to perform similarly. The latest FSN provides important additional information on cumulative survival rates* for devices both within and outside the advisory subset population to help with future patient management.*United States data, correct up to 21 July 2014