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, analysis of the device memory indicated undersensing information.Analyst commented, recommended replacement time (rrt) was triggered on (b)(6) 2016.Daily battery trend data shows gradual rise battery impedance.Early rrt alert, without corresponding battery depletion.Several electrocardiogram revealed undersensing.(b)(4).
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It was reported that during use the implantable cardiac monitor (icm) triggered recommended replacement time (rrt) and was reported as premature battery depletion.It was also reported that undersensing was noted.Evaluation of data transmission indicated the icm had an incident where an algorithm falsely triggered rrt.However, the icm will continue to function in spite of the false rrt indication.The icm will be able to transmit non-wirelessly throughout a typical life expectancy for icm devices, and the patient will be able to transmit data manually.The icm remains in use, and no patient complications have been reported as a result of this event.
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