BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX JT 45

    MDR report key: 1902839 · Received November 12, 2010

    Report

    Report Number
    1028232-2010-02433
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    June 15, 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 CAPPED DUE HIGH THRESHOLDS ON THE ATRIAL LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX JT 45 PACER LEAD NVZ BIOTRONIK SE & CO. KG 346369

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization