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Model Number 2102 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Drug Resistant Bacterial Infection (4553)
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Event Date 04/05/2022 |
Event Type
Injury
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Event Description
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A barostim system was implanted on (b)(6) 2022.The patient developed symptoms of an infection, including swelling at the neck incision, and was hospitalized on (b)(6) 2022.The patient was treated with iv antibiotics from (b)(6) 2022 through (b)(6) 2022.The patient was discharged on (b)(6) 2022 on oral antibiotics, and an explant was scheduled for (b)(6) 2022.The patient was re-admitted on (b)(6) 2022 in preparation for the explant on (b)(6) 2022.During the procedure, the pocket was washed out, and a culture taken.The barostim system was not explanted.The patient remained hospitalized on antibiotics.Culture results came back as methicillin-resistant staphylococcus aureus (mrsa), and a second procedure was performed on (b)(6) 2022 to explant the system.As of (b)(6) 2022, the patient remained hospitalized and on antibiotics.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Additional information has been requested, and a supplemental report will be submitted when received.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 as well as sterilization requirements.Cvrx id# (b)(4).
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Manufacturer Narrative
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Cvrx id: (b)(4).
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Event Description
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A barostim system was implanted on (b)(6) 2022.The patient developed symptoms of an infection, including swelling at the neck incision, and was hospitalized on (b)(6) 2022.The patient was treated with iv antibiotics from (b)(6) 2022 through (b)(6) 2022.The patient was discharged on (b)(6) 2022 on oral antibiotics, and an explant was scheduled for (b)(6) 2022.The patient was re-admitted on (b)(6) 2022 in preparation for the explant on (b)(6) 2022.During the procedure, the pocket was washed out, and a culture taken.The barostim system was not explanted.The patient remained hospitalized on antibiotics.Culture results came back as methicillin-resistant staphylococcus aureus (mrsa), and a procedure was performed on (b)(6) 2022 to explant the system, and the patient remained on oral antibiotics post explant.As of (b)(6) 2022, the patient had been released from the hospital, but the site declined to provide information on if the infection cleared.
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Search Alerts/Recalls
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