The results of the investigation are inconclusive at this time, and the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.The device history and sterilization record for this device serial number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.(b)(4).
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A barostim system was implanted on (b)(6) 2023.On (b)(6) 2023, the patient experienced "oozing" from the pocket.It was noted the pocket had eroded, and the ipg was visible through the skin.The patient was sent for a surgical consult.It was noted the patient had failed antibiotics multiple times.An infection was diagnosed on (b)(6) 2023.The ipg and a portion of the csl were explanted on (b)(6) 2023 with iv antibiotics administered during the explant, and oral antibiotics administered following the explant.A blood culture was performed, and results later returned as negative, indicating a blood or systemic infection was not present.The root cause of the event was unable to be determined.As of (b)(6) 2023, the patient was doing very well, and the removal incisions were healing appropriately.
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