Section b3: 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 oral antibiotics.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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Related manufacturer reference number: 1627487-2024-08069, 3006705815-2024-02776, 1627487-2024-08070, 3006705815-2024-02777.It was reported that patient developed an infection at the ipg and midline lead incision site.It was noted that there was puss, redness, and inflammation at infection sites.Patient was prescribed oral antibiotics and cultures/bloodwork were obtained.Results of cultures/bloodwork is unknown.Surgical intervention was undertaken wherein the system was explanted with no complications.
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