BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 1151390 · Received September 4, 2008

    Report

    Report Number
    1028232-2008-01071
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 29, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS RETURNED WITH OOS DOCUMENTATION FROM BIOTRONIK REPRESENTATIVE VERONICA CARAFFA. PER VERONICA CARAFFA, THIS LEAD BECAME DISLODGED. PER THE OOS, THIS LEAD WAS IN THE SVC AND COULD NOT BE REPOSITIONED. THIS LEAD WAS REMOVED DUE TO SCAR TISSUE. THIS LEAD WAS REPLACED WITH ANOTHER SETROX S 53.

    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 Hospitalization