Related manufacturer report number: 1627487-2024-07158, 1627487-2024-07162, 1627487-2024-07163.It was reported that the patient had an infection at the ipg and lead sites.As a result, the patient underwent surgical intervention during which the system was explanted.
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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.As a result, a device history record was performed to review and confirm the sterility of the ipg and lead(s).Based on the documents reviewed, the source of the infection remains unknown.
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