BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 60

    MDR report key: 1874480 · Received October 14, 2010

    Report

    Report Number
    1028232-2010-02197
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT COMPLAINED OF POCKET STIMULATION AND INTERMITTENT LOSS OF CAPTURE WAS OBSERVED ON THIS RV LEAD. THE PATIENT WAS SCHEDULED FOR A LEAD REVISION PROCEDURE. THE POCKET WAS REOPENED AND THE RV LEAD TESTED APPROPRIATELY WITH THE ANALYZER. FOLLOWING POCKET CLOSURE, THE LEAD FUNCTIONED APPROPRIATELY. THIS DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 60 PACER LEAD NVZ BIOTRONIK SE & CO. KG 350975

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization