BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELOX ST 53

    MDR report key: 1101305 · Received August 5, 2008

    Report

    Report Number
    1028232-2008-00829
    Event Type
    Injury
    Date Received
    August 5, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 7, 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 REP, THIS SYSTEM WAS REMOVED DUE TO INFECTION. PER THE MDRF, THIS DEVICE WAS REPLACED WITH A SELOX ST 60. EXPLANTED SYSTEM: PHILOS II DR, MDR: 1028232-2008-00827. SELOX JT 53, MDR: 1028232-2008-00828. SELOX ST 53, MDR: 1028232-2008-00829.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX ST 53 PACER LEAD DTB BIOTRONIK GMBH AND CO. 346366

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization