BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 LESION NT1100¿ PAIN MANAGEMENT RF GENERATOR

    MDR report key: 6983791 · Received October 27, 2017

    Report

    Report Number
    3002953813-2017-00035
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    September 29, 2017
    Report Date
    October 27, 2017
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXD
    PMA / PMN Number
    K052878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE SERVICE COMPLETED, THE REPORTED TEMPERATURE ISSUE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    DURING AN ABLATION PROCEDURE, THE TEMPERATURE WOULD NOT REACH 80 DEGREES. TROUBLESHOOTING INCLUDED CABLE REPLACEMENT, BUT RESOLUTION WAS NOT FOUND. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763642 3 LESION NT1100¿ PAIN MANAGEMENT RF GENERATOR GENERATOR, LESION, RADIOFREQUENCY GXD NEUROTHERM, INC RFG-NT-1100 11741-10

    Patients

    Seq Age Sex Outcome Treatment
    1