BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE 945DSN2299 13MM 27G 2.5M DUAL

    MDR report key: 2573517 · Received May 14, 2012

    Report

    Report Number
    1045254-2012-00300
    Event Type
    Malfunction
    Date Received
    May 14, 2012
    Date of Event
    April 12, 2012
    Report Date
    April 27, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    GXZ
    PMA / PMN Number
    K053363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    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 POST SURGERY, "EMG TECHNICIANS REMOVED EMG [ELECTRODE] LEADS AND MADE [NURSE] AWARE THAT THERE WERE PIN PRICK SIZE BURNS BILATERALLY ON THE PATIENT'S ANKLES FROM WHERE THE LEADS WERE. SERVICE WAS MADE AWARE. BURNS WERE LEFT OPEN TO AIR." 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 XOMED MFG JACKSONVILLE 945DSN2299 NOT PROVID

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR