BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 60

    MDR report key: 2839095 · Received November 13, 2012

    Report

    Report Number
    1028232-2012-02775
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 30, 2012
    Manufacturer
    BIOTRONIK, INC., TECHNICAL SERVICES
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS SYSTEM WAS REMOVED DUE TO A BACTERIAL INFECTION AND EROSION. THERE IS NO INDICATION THAT THE SYSTEM HAS BEEN REPLACED YET. THE HOSPITAL RETAINED THE DEVICES. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 60 PACER LEAD NVZ BIOTRONIK, INC., TECHNICAL SERVICES 350975

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization