Device remains implanted following repositioning.There is no further investigation possible.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.If further information is received, a supplemental mdr will be sent.This event appears to be related to patient's condition/comfort rather than a device problem of any kind.(b)(4).
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