BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 451

    MDR report key: 1060880 · Received June 13, 2008

    Report

    Report Number
    1028232-2008-00630
    Event Type
    Injury
    Date Received
    June 13, 2008
    Report Date
    May 12, 2008
    Manufacturer
    BIOTRONIK, GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER DEVICE TRACKING, THIS SYSTEM WAS REMOVED DUE TO INFECTION, WHICH THEY WERE INFORMED ABOUT WHEN QUESTIONING WHY THEY'D GOTTEN TWO MDRF FORMS FOR THIS PT WITHIN 2 MONTHS OF EACH OTHER. REP DID NOT KNOW PT HAD SYSTEM REMOVED FOR INFECTION UNTIL HE WENT IN TO IMPLANT NEW SYSTEM. EXPLANT AND EVENT DATES ARE UNAVAILABLE. A NEW LUMAX AND LINOX WERE IMPLANTED IN 2008. ALSO ASSOCIATED WITH THIS REPORT: LUMAX 340 DR-T, MDR: 1028232-2008-00629. LINOX TD 65/18, MDR: 1028232-2008-00631.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 451 PACER LEAD DTB BIOTRONIK, GMBH AND CO. 350973

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization