Event date is estimated.A patient had their system explanted due to infection was reported to abbott.Antibiotics were administered to the patient to address the issue.As a result, a device history record was performed to review and confirm the sterility of devices.Based on the documents reviewed, the source of the infection remains unknown.
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Related manufacturer report number:3006705815-2023-00792, 3006705815-2023-00794, 1627487-2023-00631, and 3006705815-2023-00796.It was reported that the patient experienced an infection.As a result, the patient's scs system was explanted in (b)(6) 2023.
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