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 record 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)(6).
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A barostim system was implanted on (b)(6) 2022.On (b)(6) 2022, the patient experienced redness and swelling at the pocket site.On (b)(6) 2022, the patient experienced pain and swelling, and the ipg pocket was open but the ipg was not exposed.A device explant was performed on (b)(6) 2022, and the csl remained in vivo.The ipg was sent to pathology for analysis, and analysis results were unavailable.The patient was released on (b)(6) 2022, and, as of (b)(6) 2022, the patient was doing well with the infection resolved.Per the physician, the root cause of the infection was unable to be determined.
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