While analysis was unable to be performed as the device was not returned, per the opinion of the physician, the root cause of the event was contributed to by the anesthesia protocol during the procedure.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.Health effect clinical code 4581: suggested codes are "volume depletion" and "elevated creatinine." cvrx id#: (b)(4).
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A barostim system was implanted on (b)(6) 2022.Shortly after, the patient experienced volume depletion with an elevated creatinine, along with blood pressure of 70/50.Medications were stopped, and a dobutamine drip was administered.A heart catheterization was performed on (b)(6) 2023.After the heart catheterization, the patient was stable, blood pressure had improved, and creatinine had decreased from 4.9 to 3.9.No additional adverse event was reported at the second follow-up.In the opinion of the physician, the anesthesia used with the procedure contributed to the event.The anesthesia protocol was sevoflurane at 1/2 mac, versed and either fentanyl or remifentanil.
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