BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 790199 · Received November 29, 2006

    Report

    Report Number
    1028232-2006-00235
    Event Type
    Injury
    Date Received
    November 29, 2006
    Date of Event
    September 9, 2006
    Report Date
    October 26, 2006
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SYSTEM EXPLANTED DUE TO INFECTION AND DISCARDED BY HOSPITAL. SETROX S 45, MDR 1028232-06-0236. PHILOS DR, MDR 1028232-06-0234.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 53 PACEMAKER DTB BIOTRONIK GMBH AND CO 331443 *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization