BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM ELECT 3.5X5CM2MM GND 24/PK

    MDR report key: 3175769 · Received June 18, 2013

    Report

    Report Number
    1045254-2013-00425
    Event Type
    Injury
    Date Received
    June 18, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 23, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    GXY
    PMA / PMN Number
    K062198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. NIM ECLIPSE CONTROLLER #945ECLC, SERIAL # (B)(4), MFR DATE 04/14/2012, NIM ECLIPSE PATIENT MODULE # 945OPM660, SERIAL # (B)(4), LOT# 205845305 MFR DATE 04/21/2012, SD NEEDLE ELECTRODE NRE1003, SERIAL/LOT # UNKNOWN, SURGEON CONTROLLED PROBE SPK1004, SERIAL/LOT # UNKNOWN. (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. METHOD: NO TESTING METHODS PERFORMED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY FOLLOWING A SPINAL FUSION PROCEDURE FOR SPONDYLOLISTHESIS, A BURN LESION WAS OBSERVED ON THE BACKSIDE OF THE PATIENT¿S THIGH. REPORTEDLY, ¿BEFORE THE SURGEON PLACED PRE-GELLED GROUND ELECTRODE ON SKIN, HE SCRUBBED PATIENT¿S SKIN BY SANDPAPER THAT PACKING WITH NIM-ECLIPSE PRE-GELLED GROUND ELECTRODE.¿ THE DURATION OF THE SURGERY WAS APPROXIMATELY 5 HOURS. THE NIM ECLIPSE SYSTEM FUNCTIONED AS INTENDED WITH NO REPORTED ISSUES. MONOPOLAR AND BIPOLAR ELECTRO-CAUTERY (ESU) DEVICES WERE USED FOR THE PROCEDURE AND THE ECLIPSE SYSTEM ALERTED USER OF ESU CAUTERY DETECTION. AFTER THE SURGERY THE SURGEON NOTICED SOME ¿ABNORMAL¿ AREAS WHEN THEY TOOK OFF THE ELECTRODES. THE FOLLOWING DAY A BURN WAS NOTICED AT THE PLACEMENT SITE OF THE PRE-GELLED GROUND ELECTRODE ON THE BACK SIDE OF THE RIGHT THIGH. PATIENT STATUS IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275176 NIM ELECT 3.5X5CM2MM GND 24/PK ELECTRODE, CUTANEOUS GXY MEDTRONIC XOMED, INC. DME1004 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Other