The mother called and stated that the patient had another complaint.In following up regarding the complaint, it was clarified that the physician was surprised that the battery was already at 18-25% as the patient was implanted about 12 months.The patient was referred for prophylactic replacement.Device history records were reviewed.The device was noted to have passed all quality inspections prior to distribution.No additional, relevant information was received to date.No known surgery has occurred to date.
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An implant & warranty form was received for the patient's battery replacement surgery, indicated to be prophylactic.Programming history was reviewed.Data was available from the date of implant until (b)(6) 2019.The last diagnostics were performed in 2018 indicating that the device was functioning as intended.It was noted that the hospital did keep the explant.No device was received to date.No additional, relevant information was received to date.
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