BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM ELECT 3.5X5CM2MM GND 24/PK

    MDR report key: 3175489 · Received June 18, 2013

    Report

    Report Number
    1045254-2013-00424
    Event Type
    Injury
    Date Received
    June 18, 2013
    Date of Event
    April 1, 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 UNKNOWN). NIM ECLIPSE PATIENT MODULE #945OPM660, SERIAL #(B)(4), (MFR DATE UNKNOWN). SD NEEDLE ELECTRODE NRE1003, SERIAL/LOT # UNKNOWN (MFR DATE UNKNOWN). SURGEON CONTROLLED PROBE SPK1004, SERIAL/LOT # UNKNOWN (MFR DATE UNKNOWN). (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. METHOD CODE: 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 APPROXIMATELY TWO DAYS AFTER A PROCEDURE FOR ¿SOC AND TUMOR REMOVAL¿ (RIGHT ACOUSTIC SCHWANNOMA), A SKIN LESION WAS OBSERVED ON THE PATIENT¿S RIGHT SHOULDER AT THE PRE-GELLED ELECTRODE SITE. REPORTEDLY, ¿BEFORE SURGEON PLACED PRE-GELLED GROUND ELECTRODE ON SKIN, HE SCRUBBED PATIENT¿S SKIN BY NRE 1003 SANDPAPER¿ PATIENT¿S SKIN AROUND PRE-GELLED GROUND ELECTRODE PLACEMENT WAS SCRATCHED.¿ THE DURATION OF THE SURGERY WAS APPROXIMATELY 8 HOURS. THE NIM ECLIPSE SYSTEM FUNCTIONED AS INTENDED WITH NO REPORTED ISSUES. AN ELECTRO-CAUTERY (ESU) DEVICE WAS NOTED TO BE USED DURING THE PROCEDURE AND THE ECLIPSE SYSTEM ALERTED USER OF ESU CAUTERY DETECTION. PATIENT STATUS IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275782 NIM ELECT 3.5X5CM2MM GND 24/PK ELECTRODE, CUTANEOUS GXY MEDTRONIC XOMED, INC. DME1004 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other