BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 45

    MDR report key: 1081797 · Received July 23, 2008

    Report

    Report Number
    1028232-2008-00785
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    May 29, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER OOS, THIS SYSTEM WAS REMOVED DUE TO INFECTION: PHILOS II DR, MDR 1028232-2008-00782. SETROX S 53, MDR 1028232-2008-00784. SETROX S 45, MDR 1028232-2008-00785.

    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 71 YR Hospitalization