BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 777040 · Received November 3, 2006

    Report

    Report Number
    1028232-2006-00239
    Event Type
    Injury
    Date Received
    November 3, 2006
    Date of Event
    September 27, 2006
    Report Date
    October 30, 2006
    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

    SYSTEM EXPLANTED DUE TO INFECTION. SETROX S 45, 1028232-06-0240; PHILOS II DR-T, 1028232-06-0238.

    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 86 YR Hospitalization