BEUDAMED
    FDA Adverse Event Other Summary report: N

    NT 1000

    MDR report key: 1271532 · Received December 19, 2008

    Report

    Report Number
    1226344-2008-00003
    Event Type
    Other
    Date Received
    December 19, 2008
    Date of Event
    November 4, 2008
    Report Date
    December 19, 2008
    Manufacturer
    NEUROTHERM, INC.
    Product Code
    GXD
    PMA / PMN Number
    K052878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO NEUROTHERM AND THOROUGHLY EVALUATED. THE COMPANY PERFORMED TESTING ON THE DEVICE AND FOUND THAT IT MEETS ALL OPERATING SPECIFICATIONS AND PARAMETERS, AND FUNCTIONS NORMALLY. THERE IS NO EVIDENCE INDICATING THAT THE DEVICE MALFUNCTIONED IN ANY WAY. BASED ON THIS EVAL, IT IS PROBABLE THAT THE EXPERIENCE WITH THE DEVICE MAY HAVE RESULTED FROM SOME TYPE OF USER ERROR, SUCH AS IMPROPER PLACEMENT OF ELECTRODES.

    Description of Event or Problem · 1

    PT COMPLAINED OF MUSCLE TWITCHING IN HIS BACK DURING THE COURSE OF A RADIO FREQUENCY (RF) NEURO-ABLATION PROCEDURE. TREATMENT WAS STOPPED, AND THE ELECTRODES WERE CHECKED TO ENSURE THEY WERE CORRECTLY POSITIONED. TREATMENT WAS THEN REINITIATED AND COMPLETED. IN THE RECOVERY ROOM THE PT COMPLAINED OF CONSIDERABLE PAIN IN THE TREATMENT REGION OF HIS BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NT 1000 RADIOFREQUENCY LESION GENERATOR GXD NEUROTHERM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other