Related manufacturer reference# 1627487-2020-32776, 1627487-2020-32781, 1627487-2020-32777, 1627487-2020-32815, 1627487-2020-32818, 1627487-2020-32815, 1627487-2020-32782 & 1627487-2020-32778
it was reported the patient¿s entire scs system was removed due to an infection at the lead and battery site.Infection was treated with iv antibiotics.The exact explant date is unknown.
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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.Attempts were made to obtain complete event and patient information.Additional information was not provided.
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