Product event summary: the device was not returned for analysis.However, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the battery impedance trend was rising.Analyst commented, recommended replacement time (rrt) was triggered on (b)(6) 2016 due to impedance.Daily battery trend data shows gradual rise battery impedance.Early rrt alert, without corresponding battery depletion.
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It was reported that during use of implantable cardiac monitor (icm) data transmission showed "battery low", though the icm battery is not low.Software update to be implanted, and the icm remains in use.No patient complications have been reported as a result of this event.
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