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.However, as neither turning barostim therapy off nor the explant of the barostim system resolved the hiccups, it is unlikely the barostim system caused the hiccups.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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On 05-sep-2023, the patient reported intermittent stimulation behind their ear, frequent hiccups, and some vomiting since their last titration on (b)(6) 2023.Barostim therapy was decreased, and the stimulation and hiccups resolved.As of (b)(6) 2023, the patient was still experiencing hiccups but no additional extraneous stim.The physician was unsure if barostim was causing the hiccups, and barostim was turned off to see if it was contributing.Barostim therapy being off did not resolve the hiccups, indicating the hiccups were not caused by barostim therapy.The patient continued to experience hiccups, and the system was explanted on 11-mar-2024 to rule out barostim as a cause for the hiccups.The patient was stable following the explant.The hiccups did not resolve following the explant, and the root cause of the hiccups was unable to be determined.
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