BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM-ECLIPSE

    MDR report key: 5548036 · Received April 5, 2016

    Report

    Report Number
    5548036
    Event Type
    Injury
    Date Received
    April 5, 2016
    Date of Event
    March 24, 2016
    Report Date
    April 1, 2016
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD THREE FULL THICKNESS BURNS (3RD DEGREE) EVIDENT AROUND THE ELECTRODE PAIR SITES OF NEUROMONITORING LEADS, COM A ELECTRODE SITE AND LEFT FIRST DORSAL INTEROSSEOUS SITE (LFD) LEAD SITE. ALL LEADS INVOLVED HAVE BEEN SET ASIDE TO KEEP FOR INVESTIGATION. ALL OTHER LEAD SITES SHOWED NO SIGN OF HEATING OR BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203658 NIM-ECLIPSE NERVE STIMULATOR ETN MEDTRONIC XOMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention YES MRI SCANNER SEAMAN 3T