BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 1013154 · Received March 12, 2008

    Report

    Report Number
    1028232-2008-00234
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    January 28, 2008
    Report Date
    February 18, 2008
    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

    THIS SYSTEM WAS REMOVED DUE TO INFECTION PER OOS. ALSO REMOVED: LUMAX 340 DR-T, MDR 1028232-2008-00233. LINOX SD 65/16, MDR 1028232-2008-00341.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 53 PACER LEAD DTB BIOTRONIK GMBH AND CO. 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization