BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 45

    MDR report key: 789071 · Received November 29, 2006

    Report

    Report Number
    1028232-2006-00268
    Event Type
    Injury
    Date Received
    November 29, 2006
    Date of Event
    November 3, 2006
    Report Date
    November 21, 2006
    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

    DEVICE SYSTEM WAS EXPLANTED DUE TO HEMATOMA AND POSSIBLY INFECTION. CYLOS DR-T, MDR 1028232-06-0268. SETROX S 53, MDR 1028232-06-0270.

    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 73 YR Hospitalization