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Model Number 1036 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Post Operative Wound Infection (2446); Insufficient Information (4580)
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Event Date 07/08/2023 |
Event Type
Injury
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Manufacturer Narrative
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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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Event Description
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A barostim system was implanted on (b)(6) 2023.On (b)(6) 2023, an incision and drainage procedure was performed at the carotid incision site and the site was very red.As of (b)(6) 2023, the patient appeared to be recovering normally, and no additional intervention was required.No adjustments were made to the barostim system.
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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) 2023.On (b)(6) 2023, an incision and drainage procedure was performed at the carotid incision site and the site was very red.It was noted the incision site was infected, but no additional details were provided by the site.As of on (b)(6) 2023, the patient appeared to be recovering normally.No additional intervention was required, and no further adverse events were reported.No adjustments were made to the barostim system.
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Search Alerts/Recalls
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