Related manufacturer reference number: 3006705815-2023-07658, 3006705815-2023-07660, 3006705815-2023-07661, 1627487-2023-05611 it was reported that the patients incisions had opened up and was diagnosed with staph infection.Surgical intervention was undertaken on (b)(6) 2023, where the system was explanted.Patient was being treated with iv antibiotics in the hospital to combat the infection.
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A patient's incisions had opened up and was diagnosed with staph infection was reported to abbott.The entire system was explanted.The patient was being treated with iv antibiotics in the hospital to combat the infection.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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