BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THYMATRON

    MDR report key: 1584251 · Received January 8, 2010

    Report

    Report Number
    1584251
    Event Type
    Injury
    Date Received
    January 8, 2010
    Date of Event
    January 6, 2010
    Report Date
    January 8, 2010
    Manufacturer
    SOMATICS LLC
    Product Code
    GXC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING ECT TREATMENT FOR BIPOLAR DISORDER. THE SKIN OF THE POST-AURICULAR, FOREHEAD, AND TEMPLE AREA WERE CLEANED WITH A PREG AGENT USING A COTTON GAUZE PAD. SALINE ON A COTTON GAUZE PAD WAS THEN APPLIED TO THE SKIN AND ALLOWED TO DRY. MONITORING ELECTRODES WERE PLACED ON THE LEFT AND RIGHT FOREHEAD AND POST-AURICULAR REGIONS. BASELINE EEG MEASURES WERE OBTAINED FROM THE THYMATRON DEVICE. ONCE ANESTHESIA WAS ACHIEVED, STIMULUS ELECTRODES WERE PLACED ON THE LEFT AND RIGHT TEMPLE, AND PRESSURE APPLIED WITH FOAM-HANDLED APPLICATORS TO THE RIGHT AND LEFT TEMPORAL STIMULUS ELECTRODE IN ORDER TO OBTAIN CIRCUIT IMPEDANCE <3000 OHMS. THEN 100% ENERGY (504 JOULE) WAS ADMINISTERED TO THE RIGHT AND LEFT TEMPLE. AN ACRID ODOR WAS DETECTED BEFORE THE PATIENT EMERGED FROM ANESTHESIA. CAREFUL PHYSICAL EXAMINATION OF THE SKIN REVEALED A PALE YELLOW DEPRESSION THAT MEASURED 3 CM X 0.5 CM IN SIZE AT NEAR THE LEFT TEMPLE WHERE THE STIMULUS ELECTRODE WAS PLACED. THE BURN SURGERY SERVICE WAS IMMEDIATELY CONSULTED. THE BURN TEAM INSTRUCTED THE PATIENT TO KEEP THE AREA CLEAN BY WASHING WITH SOAP AND WATER DAILY, APPLY BACITRACIN OINTMENT SEVERAL TIMES DAILY IN ORDER TO KEEP THE AREA MOIST, AND TO LEAVE THE WOUND OPEN TO THE AIR WITHOUT ANY ADDITIONAL GAUZE COVERING. WE HAVE DISCUSSED THIS EVEN WITH THE MANUFACTURER. THE MANUFACTURER SAYS THAT THE BURNS ARE CAUSED BY EITHER THE PADS BEING TOO DRY, IMPROPER SKIN PREPARATION, OR MOISTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THYMATRON DEVICE, ELECTROCONVULSIVE THERAPY GXC SOMATICS LLC SYSTEM IV *
    2 THYMATRON E-PAD ELECTRODES, DEVICE, ELECTROCONVULSIVE THERAPY GXC SOMATICS LLC * 917701

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other| R