BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 45

    MDR report key: 1081804 · Received July 23, 2008

    Report

    Report Number
    1028232-2008-00792
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 25, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER THE OOS, THE ATRIAL LEAD WAS REPLACED. PER BIOTRONIK REP, THIS LEAD BECAME DISLODGED AND COULD NOT BE REPOSITIONED. THIS LEAD WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 45 PACER LEAD DTB BIOTRONIK GMBH AND CO. 350973

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization