BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RFG-3CF SYSTEM, 100V/50HZ

    MDR report key: 614593 · Received July 20, 2004

    Report

    Report Number
    1717344-2004-00066
    Event Type
    Malfunction
    Date Received
    July 20, 2004
    Date of Event
    August 25, 2003
    Report Date
    July 20, 2004
    Manufacturer
    VALLEYLAB
    Product Code
    GDX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    2003. PROCEDURE: GANGLIONOLYSIS. BASED UPON THE INFORMATION REPORTED IN THE OPERATIVE REPORT: THE PATIENT WAS SEDATED AND THE ELECTRODE WAS INSERTED THROUGH THE LEFT FORAMEN OVALE. AFTER PLACEMENT OF THE ELECTRODE THE SETTINGS ON THE UNIT WERE CHANGED FROM STIMULATION TO LESION MODE, AND THERE WAS NO EVIDENCE OF HEAT BEING GENERATED FROM THE ELECTRODE TIP. THE SETTINGS AND THE ELECTRODES WERE CHANGED BUT THE DEVICE STILL DID NOT WORK THE DOCTOR REPORTS "REPEATED NEUROLOGICAL, EXAMINATIONS DURING AFTER THE TRIAL SHOWED NO EVIDENCE OF NEUROLOGICAL DEFICIT." THE FOLLOWING MONTH, BASED UPON THE INFORMATION IN THE DOCTORS FOLLOW UP REPORT, THE PATIENT REPORTED RESOLUTION OF PREOPERATIVE PAIN DESPITE THE FACT THAT NO HEAT WAS DELIVERED DURING THE PROCEDURE. NO BUCCAL TRAUMA WAS NOTED. TEGRETOL WAS PRESCRIBED. 2004. BASED ON THE REPORT OF A CONSULTING PHYSICIAN, THE PATIENT TRIED TO GO FFO THE TEGRETOL BUT FACIAL PAIN WORSENS. THE PATIENT HAS, "RESIDUAL NUMBNESS OF THE CHEEK ON THE LEFT SIDE..SAYS THEIR TONGUE IS ALSO NUMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RFG-3CF SYSTEM, 100V/50HZ RADIOFREQUENCY GENERATOR GDX VALLEYLAB * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR