Following a refill performed by a nurse, the patient reportedly "blacked out" and paramedics were called.The patient declined to go to the hospital, but narcan was administered.This narcan treatment was effective for three hours until the patient began having difficulty staying awake.The nurse then drained and turned off the patient's pump.The patient's physician refilled the pump three days later.
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A review of the device history record, which includes verification of all steps in the manufacturing of the pump, verification of all final testing performed by/on the pump, verification of sterilization, and packaging for subject pump was performed.The review did not identify any non-conformances, issues or capas associated with pump function.Device remains implanted and was not returned for additional evaluation and investigation.Several follow-up attempts were made with the physician's office, but these were unsuccessful.Per the instructions for use of the device, refill errors such as pocket fill are known possible risks of use of the device.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).
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