BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTELECT LEGEND STIM

    MDR report key: 1002358 · Received February 22, 2008

    Report

    Report Number
    1022819-2008-00052
    Event Type
    Other
    Date Received
    February 22, 2008
    Date of Event
    January 31, 2008
    Report Date
    February 18, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    LIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING RETURN AND EVAL OF THE DEVICE.

    Description of Event or Problem · 1

    CLINICIAN CONDUCTED AN ELECTROTHERAPY TREATMENT ON THE PT'S RIGHT SHOULDER AREA. THE ELECTROTHERAPY TREATMENT WAS PERFORMED IN CONJUNCTION WITH A HEAT THERAPY. THE HEAT THERAPY DEVICE AND MANUFACTURE IS NOTED AS THERMAFOR. THE BURN WAS NOTED UPON COMPLETION OF TREATMENT. THE PT SUFFERED ONE - 3RD DEGREE BURN, DIAMETERS OF BURN(S) IS ESTIMATED AT 1CM, IN THE TREATMENT AREA OF THE ELECTRODES. THE CLINICIAN DID NOT KNOW IF THE PT SOUGHT POST MEDICAL TREATMENT FOR THE BURN(S). THE PT HAD RECEIVED ELECTROTHERAPY TREATMENTS (6) PRIOR TO THIS INCIDENT. THE CLINICIAN TREATED THE PT USING 4 POLE INTERFERENTIAL TREATMENTS (IFC). THE SETTINGS ARE DEFAULT CONSTANT VOLTAGE SETTINGS. THE TREATMENT SESSION INTENSITY IS 'INCREASED TO TOLERANCE.' THE TREATMENT SYMPTOM IS LOWER BACK PAIN. THE TREATMENT TIME WAS SET FOR 12 MINUTES. THE CLINICIAN COULD NOT DETERMINE THE CONDITION OF THE ELECTRODES. THE PT WAS NOT HOLDING THE PT SWITCH. ARE YOU AWARE OF ANY OTHER PT INCIDENTS WITH THIS EQUIPMENT OR OTHER CHATTANOOGA GROUP EQUIPMENT THAT MIGHT BE IN OPERATION AT YOUR LOCATION?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELECT LEGEND STIM POWER MUSCLE STIMULATOR LIH CHATTANOOGA GROUP INT002

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other