BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEGEND XT

    MDR report key: 1039020 · Received May 6, 2008

    Report

    Report Number
    1022819-2008-00134
    Event Type
    Other
    Date Received
    May 6, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 30, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    GZJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IPF, STIMULATOR, MUSCLE, POWERED. GZI, STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL. HCC, DEVICE, BIOFEEDBACK. IMG, STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT.

    Description of Event or Problem · 1

    PATIENT RECEIVED ONE 3RD DEGREE BURN APPROXIMATELY 1CM IN DIAMETER DURING AN ELECTROTHERAPY TREATMENT. THE PATIENT WAS BEING TREATED FOR LOWER BACK PAIN. THE CLINICIAN PRESCRIBED THE INTERFERENTIAL WAVEFORM (IFC) FOR THE SYMPTOM. THE EXACT SETTINGS OF THE IFC TREATMENT COULD NOT BE SPECIFIED BY THE CLINICIAN. THE CLINICIAN DID INDICATE AN OUTPUT SETTING OF LESS THAN 45MA. THE ELECTRODES USED FOR THE TREATMENT WERE SELF ADHESIVE AND 2.5X4 IN SIZE. THE CLINICIAN DID REPORT THAT THE ELECTRODES HAD BEEN USED BY THE PATIENT IN PREVIOUS TREATMENTS, ESTIMATED TO BE LESS THAN 10 USES. THE TREATMENT TIME WAS FOR 20 MINUTES. THE PATIENT HAD RECEIVED ELECTROTHERAPY TREATMENT PRIOR TO THIS INCIDENT WITH NO ADVERSE EFFECTS OR REACTIONS. THE PATIENT DID NOT REQUIRE IMMEDIATE OR POST MEDICAL TREATMENT AS A RESULT OF THE INCIDENT. THE PATIENT IS REPORTED TO MAKE A FULL RECOVERY FROM THE INCIDENT. THE CLINICIAN ALSO NOTED THAT THE INCIDENT OCCURRED AFTER THE INSTALLATION OF THE FIELD CORRECTION SOFTWARE. UNOPENED PACKAGE OF ACCESSORIES. NO PADS WERE SENT WITH THE UNIT FOR EVALUATION, LEADS WERE GOOD. NO ROOT CAUSE CAN BE DETERMINED IF THE CUSTOMER COMPLAINT IS NOT REPRODUCED. AFTER RUNNING THE SAME TREATMENT AS DESCRIBED, NO PROBLEMS WAS DETECTED. ROOT CAUSE IS USER MISUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGEND XT GZJ, STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF, 882.5810 GZJ CHATTANOOGA GROUP 2788

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other