BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 53

    MDR report key: 2771483 · Received September 28, 2012

    Report

    Report Number
    1028232-2012-02423
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 13, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS REMOVED AND REPLACED BECAUSE THE R WAVE AMPLITUDE HAD DIMINISHED AND THE PACING THRESHOLD HAD MORE THAN QUADRUPLED. IT SHOULD BE NOTED THAT THE PT WORE A VERY HEAVY BACKPACK AND THAT IS SUSPECTED TO HAVE CAUSED THE DAMAGE. THE HOSPITAL RETAINED THE DEVICE. SHOULD ADD¿L INFO BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 53 PACER LEAD NVZ BIOTRONIK SE & CO. KG 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization