BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE 945DSN2299 13MM 27G 2.5M DUAL

    MDR report key: 2566856 · Received May 9, 2012

    Report

    Report Number
    1045254-2012-00278
    Event Type
    Injury
    Date Received
    May 9, 2012
    Date of Event
    July 12, 2011
    Report Date
    April 11, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    GXZ
    PMA / PMN Number
    K053363
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). NO MEDWATCH 3500A FORM WAS RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON THIS FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER. ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION WERE MADE, AND THE RECORDS OF THESE ATTEMPTS ARE DOCUMENTED IN THE COMPLAINT FILE. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE IN QUESTION WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. AS THE LOT NUMBER IS UNKNOWN, A REVIEW OF THE DEVICE HI STORY RECORDS COULD NOT BE CONDUCTED. DEVICE DESCRIPTION: STAINLESS STEEL SUBDERMAL NEEDLE ELECTRODES. INTENDED USE: SUBDERMAL ELECTRODES ARE PLACED SUBCUTANEOUSLY TO STIMULATE OR RECORD ELECTRICAL SIGNALS WITH THE NERVE INTEGRITY MONITOR OR OTHER EMG MONITORS. INDICATIONS: THE ELECTRODES ARE INDICATED FOR INTRAOPERATIVE MOTOR NERVE LOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, "PATIENT PRONE ALL DAY FOR BACK SURGERY. WHEN PATIENT FLIPPED TO BACK DISCOVERED BURNS TO BILATERAL ANKLES FROM EMG [ELECTRODE] LEADS. ALSO, ERYTHEMA TO CHIN WHICH IS ALSO RAISED." THE FACILITY REPORTED THEY "REACHED-TEMP HARM, INTERVENTION." NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRODE 945DSN2299 13MM 27G 2.5M DUAL ELECTRODE, NEEDLE GXZ MEDTRONIC XOMED, INC. 945DSN2299 NOT PROVID

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention