An event of infection was reported to abbott.It was conveyed that the infection originates at the 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 lead(s).Based on the documents reviewed, the source of the infection remains unknown.B3-date of event is estimated.During processing of this incident, attempts were made to obtain complete patient information.Further information was requested but not received.(patient weight is unknown).
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