BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NT500

    MDR report key: 2841503 · Received October 12, 2012

    Report

    Report Number
    2841503
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    September 27, 2012
    Report Date
    October 12, 2012
    Manufacturer
    NEUROTHERM
    Product Code
    GXD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO DO A RADIO FREQUENCY ABLATION FOR THE PATIENT WE WERE UNABLE TO GET A TEMPERATURE READING ON THE GENERATOR. AT LEAST 2 CANNULAS, 2 DISPOSABLE PROBES, AND ONE BRAND NEW ADAPTER CABLE WERE ALL TRIED WITHOUT SUCCESS. A NON-DISPOSABLE PROBE WAS EVENTUALLY TRIED WITH SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NT500 GENERATOR, LESION, RADIOFREQUENCY GXD NEUROTHERM NT500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR