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 the right side on (b)(6) 2023.The patient experienced left-side facial drooping and difficulty swallowing following the procedure.The opinion of the physician was that the issue could be related to a opposed facial nerve that was affected during the implant procedure, but suggested an mri for additional details.An mri was planned to rule out a stroke or transient ischemic attack (tia), however, the patient refused the mri.As of (b)(6) 2023, the facial drooping improved as post-implant swelling decreased.As of (b)(6) 2023, the facial swelling had completely resolved.
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