BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 45

    MDR report key: 1201549 · Received October 16, 2008

    Report

    Report Number
    1028232-2008-01263
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    July 31, 2008
    Report Date
    September 17, 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
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER MDRF, THIS SYSTEM WAS REMOVED DUE TO INFECTION: LUMAX 340 HF-T, MDR 1028232-2008-01262. COROX OTW 75-UP STEROID, MDR 1028232-2008-01265. LINOX SD 65/18, MDR 1028232-2008-01266. LINOX SD 65/16, MDR 1028232-2008-01432.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 45 PACER LEAD DTB BIOTRONIK, GMBH AND CO. 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization