This event occurred outside the us 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.Recommended replacement time (rrt) was triggered on (b)(6) 2016.Daily battery trend data shows gradual rise of battery impedance.Early rrt alert, without corresponding battery depletion.(b)(4).
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