Health Canada — Medical Devices · Canada · 2021-02-19 · Type II
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Reported risk: Notification informing customers of a potential issue for a subset of Implantable Cardioverter Defibrillators (ICDs) and Cardiac Esynchronization Therapy Defibrillators (CRT-DS). Medtronic has identified that a small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation. The subset of ICDs and CRT-DS affected by this issue were last implanted in February 2019 and manufactured with a specific battery design that is no longer being distributed. The rapid depletion is caused by a latent shorting mechanism involving lithium plating, resulting from a thermal gradient between the anode and cathode components of the battery. Devices with higher pacing outputs and high pacing percentages (e.g. CRT-D devices) have the lowest probability of occurrence. Conversely, devices with low current drain (evidenced by a longer overall service time from implant to RRT) have a higher probability of experiencing this issue. The probability of this issue developing is constant after approximately three years of service time.
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