BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM-ECLIPSE® ELECTRODE

    MDR report key: 5657944 · Received May 16, 2016

    Report

    Report Number
    1045254-2016-00152
    Event Type
    Injury
    Date Received
    May 16, 2016
    Date of Event
    December 1, 2015
    Report Date
    April 21, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: 945ECLC: CONTROLLER 945ECLC ECLIPSE, S/N (B)(4), LOT 206744915, MANUFACTURED: 02/27/2013, 510K: K050798. PRODUCT EVALUATION: ANALYSIS RESULTS NOT AVAILABLE; DEVICE NOT RETURNED FOR EVALUATION.

    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 "A SIGNIFICANT FULL THICKNESS BURN WAS NOTICED UPON UN-DRAPING THE PATIENT BY CSI RN, AND THE SURGICAL TEAM REVIEWED. AN ASSUMPTION WAS MADE BY THE RESIDENT THAT IT WAS CAUSED BY NEUROMONITORING WHILE IN THE MRI." AFTER WOUND CARE AND PLASTICS CONSULT THE PATIENT IS NOW DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310456 NIM-ECLIPSE® ELECTRODE ELECTRODE, NEEDLE GXZ MEDTRONIC XOMED, INC. 945DSN2280

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention