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.Cvrx id# (b)(4).
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A barostim system was implanted on (b)(6) 2023.On (b)(6) 2023, it was reported that the patient presented in a febrile state and ipg pocket redness, was admitted to the hospital, and a pocket infection was diagnosed.It was noted that the infection began several days post implant.An ipg and csl explant occurred on (b)(6) 2023, and oral and iv antibiotics were administered.The root cause of the infection and the infection type was unable to be determined.On an unknown date, the patient was discharged.The patient was reported to be recovering on (b)(6) 2023.
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