BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM-ECLIPSE® ELECTRODE

    MDR report key: 5637949 · Received May 6, 2016

    Report

    Report Number
    1045254-2016-00133
    Event Type
    Injury
    Date Received
    May 6, 2016
    Date of Event
    March 24, 2016
    Report Date
    April 12, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GXZ
    PMA / PMN Number
    K050194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 945ECLC: CONTROLLER 945ECLC ECLIPSE, S/N (B)(4), LOT 206744915, MANUFACTURED: 02/27/201,3 PRODUCT CODE: GWF, 510K: K050798. PRODUCT EVALUATION: ANALYSIS RESULTS NOT AVAILABLE; DEVICE NOT RETURNED FOR EVALUATION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 AFTER A PROCEDURE TO ADDRESS RIGHT ANTERIOR VERTEBRAL TETHERING FROM T11-L3, THE "PATIENT HAD THREE FULL THICKNESS BURN (3RD DEGREE) EVIDENT AROUND THE ELECTRODE PAIR SITES OF NEUROMONITORING LEADS, COM A ELECTRODE SITE AND LEFT FIRST DORSAL I NTEROSSEOUS SITE (LFD) LEAD SITE. ALL OTHER LEAD SITES SHOWED NO SIGN OF HEATING OR BURN." IT WAS CONFIRMED THAT THE PATIENT'S BURNS HAVE HEALED AND THAT NO INTERVENTIONS WERE REQUIRED TO TREAT THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292405 NIM-ECLIPSE® ELECTRODE ELECTRODE, NEEDLE GXZ MEDTRONIC XOMED INC. 945DSN2280

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other