BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THYMAPAD STIMULUS ELECTRODES

    MDR report key: 2000397 · Received February 18, 2011

    Report

    Report Number
    MW5019475
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 18, 2011
    Manufacturer
    SOMATICS, LLC
    Product Code
    GXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS PREPPED FOR ECT BY PLACING A SURGICAL CAP OVER ALL HER HAIR, WASHING HER FOREHEAD WITH WATER AND COMPLETELY DRYING, THEN APPLYING 3 DROPS OF "PRE TAC" TO GAUZE AND CLEANSING THE AREA AGAIN, ALLOW IT TO AIR DRY, THEN THE THYMATRON ELECTRODES WERE APPLIED TO THE SKIN, TAKING SPECIAL CARE THAT NO HAIR WAS UNDERNEATH THE ELECTRODES. WHEN THE ELECTRICAL CURRENT WAS INTRODUCED BY THE PHYSICIAN, A SLIGHT BURNING ODOR AND SPARKING NOISE WAS NOTED FROM THE AREA OF THE ELECTRODES (THE RIGHT FRONTAL AREA). CURRENT WAS IMMEDIATELY CUT OFF. THE ELECTRODES WERE GENTLY REMOVED AND A SMALL PIN HEAD SIZED POINT WHITE LESION WAS NOTED WHERE THE ELECTRODE HAD BEEN PLACED. ALSO NOTED A SMALL ROUND AREA OF WHITE BURN ON THE TACKY SIDE OF THE ELECTRODE AT THE DISTAL END WHERE THE WIRES ENTER THE PAD. THE AREA ON THE SKIN CORRESPONDED TO THE BURN AREA ON THE ELECTRODE PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THYMAPAD STIMULUS ELECTRODES ECT ELECTRODE GXC SOMATICS, LLC 031617

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other