This companion external battery was not in use by a pt.A syncardia clinical support rep reported that she removed a companion external battery from service at an implant site because it did not hold a charge.This alleged failure mode poses a low risk to a pt, because the issue was observed when the external battery was not in use by a pt.In addition, the reported issue would not prevent a companion 2 driver from performing its life-sustaining functions.Companion 2 drivers have redundant sources of power.An investigation will be conducted by syncardia, and the results will be provided in a supplemental mdr.
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