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 related to a surgical issue or the patient touching the wound; and it was not caused by the cvrx device.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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A barostim system was implanted on (b)(6) 2023.During a wound check, a seroma was observed at the chest pocket and carotid site.The seroma was evacuated, and lovenox was discontinued.As of (b)(6) 2023, the patient had no further redness, swelling, discharge or dehiscence at the seroma site, and the patient was doing well with barostim therapy.In the opinion of the physician, the issue was related to a surgical issue or the patient touching the wound; not a device issue.
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