This event occurred outside the u.S.Where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.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) 2015.Daily battery trend data shows gradual rise battery impedance.Early rrt alert, without corresponding battery depletion.(b)(4).
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It was reported that during use, at remote followup, the implantable cardiac monitor (icm) displayed an early recommended replacement time (rrt) indicator due to an incident where an algorithm falsely triggered rrt.The icm remains in use.The icm will continue to function in spite of the false rrt indication.Should eos trigger, the device will automatically switch to non-wireless telemetry only.The patient will be able to transmit manually (or non-wirelessly with the patient wand).No patient complications have been reported as a result of this event.
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