Carelink Programmer System (2019-10-04) — recall 60055
Health Canada — Medical Devices · Canada · 2019-11-01 · Type II
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Reported risk: This notification is to inform customers of the potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality. Furthermore, the recommended replacement time (RRT) remains an accurate indicator for device replacement. The cause of the inaccurate longevity estimate is a slightly lower-than-typical discharge voltage during the plateau phase of the battery depletion curve, compared to a typical voltage plateau. During this plateau period, the carbon monofluoride (CFX) in the battery cathode is powering the device. Longevity estimates early after implantation and later in the device life are unaffected. The battery remains within operating specifications.
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