The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.If additional information is received, a supplemental report will be submitted.The device history 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.Cvrx id# (b)(4).
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A barostim system was implanted on (b)(6) 2022.The patient experienced a hematoma at the pocket site on 11-may-2022 and was admitted to the hospital on 12-may-2022.The hematoma was washed out, and there were no signs of infection.The patient was discharged on 13-may-2022.At the follow-up appointment on 31-may-2022, the patient was doing well.
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