BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 LESION NT2000 PAIN MANAGEMENT RF GENERATOR

    MDR report key: 11821535 · Received May 13, 2021

    Report

    Report Number
    3002953813-2021-00001
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    January 8, 2020
    Report Date
    May 13, 2021
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXD
    UDI-DI
    05415067022417
    PMA / PMN Number
    K111576
    Removal / Correction Number
    2184149-04/22/21-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVEALED THAT THE CAPACITOR ON THE RF CONTROL BOARD FAILED WITHIN TWO YEARS OF SERVICE.

    Description of Event or Problem · 1

    THE GENERATOR DID NOT REACH DESIRED TEMPERATURE. NO FURTHER INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719922 4 LESION NT2000 PAIN MANAGEMENT RF GENERATOR GENERATOR, LESION, RADIOFREQUENCY GXD NEUROTHERM, INC RFG-NT-2000 7251991 05415067022417

    Patients

    Seq Age Sex Outcome Treatment
    1