Related manufacturer report number: 3006705815-2024-00847, 3006705815-2024-00848, 3006705815-2024-00849, and 1627487-2024-00550.It was reported that the patient had an infection at the ipg and lead site and was given antibiotics.As a result, the patient underwent surgical intervention during which the system was explant and the patient was given further antibiotics.The infection was later resolved.
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Date of event is estimated.An event of infection was reported to abbott.It was conveyed that the infection originates at the ipg and lead site(s).The entire system was explanted; however, no explanted products were returned for analysis.The patient was treated with antibiotics and the infection has resolved.As a result, a device history record was performed to review and confirm the sterility of the ipg and lead site(s).Based on the documents reviewed, the source of the infection remains unknown.
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