BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 1061223 · Received June 13, 2008

    Report

    Report Number
    1028232-2008-00649
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 21, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER THE OOS, "DURING A DISSECTION OF ATRIAL LEAD IN POCKET; THIS LEAD BECAME DISLODGED AND UNABLE TO BE REPOSITIONED, SO IT WAS REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 53 PACER LEAD DTB BIOTRONIK GMBH AND CO. 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention