It was reported that the patient had a battery replacement and all went well.The implant card was received and indicated the reason for replacement was due to wound revision.It is unknown at this time if there was an issue with the generator wound site.Device history record's for the generator was reviewed.The generator passed final quality and functional specifications prior to release.The device was sterilized prior to being distributed.Per the facility the surgery took place, all explants are discarded during surgery.Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.No additional relevant information has been received to date.
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