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.As additional investigation was not performed, a definitive root cause could not be determined for the alleged issue.Several attempts were made to follow up for additional information with the nurse reported to have covered the issue, but the attempts were unsuccessful.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).
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