Related manufacturer report number: 1627487-2024-00353, 3006705815-2024-00605, 3006705815-2024-00604, 1627487-2024-00352.It was reported that the patient experienced a staph infection at the incision sites of their scs system.The patient noted experiencing painful bubbling at the ipg site as well as fluid release at their incision sites.Surgical intervention was undertaken on (b)(6) 2022 wherein the patient's system was reportedly explanted to address the issue.
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A patient experienced a staph infection at the incision sites of their scs system was reported to abbott.The patient noted experiencing painful bubbling at the ipg site as well as fluid release at their incision sites.The patient's system was explanted 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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