BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 45

    MDR report key: 1902838 · Received November 12, 2010

    Report

    Report Number
    1028232-2010-02412
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 18, 2010
    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
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS REMOVED AND REPLACED DUE TO INTERMITTENT OVERSENSING AND POSSIBLE CLAVICULAR CRUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 45 PACER LEAD NVZ BIOTRONIK SE & CO. KG 350973

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization