The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received from the site, the hematoma could have been related to the anticoagulant medication the patient was taking; however, the cause of the infection was unable to be undetermined.The device history and sterilization records 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.(b)(4).
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A barostim system was implanted on (b)(6) 2022.The patient was admitted to the hospital on (b)(6) 2022 due to hematoma at the pocket site.It was noted that the patient was taking an anticoagulant medication.An infection culture was performed, and proteus mirabilis was detected.The hematoma site was evacuated, and moderate old liquified hematoma was observed with no gross signs of infection.The pocket was irrigated with saline with a flow seal, the ipg was placed in an absorbable antibiotic pouch, and oral antibiotics were administered.Therapy remained activated, and the patient experienced functional improvement in their heart failure.The patient was discharged home on (b)(6) 2022 with the infection controlled.
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