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.Issue was determined to be due to user error during refill procedure.Patient is currently doing well.Per the instructions for use of the device, refill errors, including injection of medication into the pump pocket, are known possible risks of use of the device.Internal complaint number: (b)(4).
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Sales representative contacted technical solutions to report a patient that had a pocket fill.Representative reported that the physician attempted to fill the patient's pump with 20 cc of 1000 mcg/ml fentanyl, and that the physician had felt resistance.Representative reported that the after the refill, the physician double checked the reservoir volume and only got 3 cc of medication back.They also reported that the physician believed that the medication entered the pocket, as the patient "was beginning to code".Representative reported that the physician was able to initially aspirate around 14-15cc of medication out of the pocket.The physician flushed and aspirated the pocket area with saline three times.The patient was reported to be stable in the er.The patient's pump constant flow daily dose was set to 0 and their patient therapy controller (ptc) was disabled for the time being.Representative reported that the physician used a medtronic refill kit during the initial refill.The patient remained in the er for two nights and was seen by the physician.Physician successfully refilled the patient's pump with 20cc of medication.The pump was reactivated to constant flow and the ptc was enabled at doctors order.The patient was reported to be doing well and there have been no issues reported after the refill.
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