BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENUINE GRASS PLATINUM SUBDERMAL, 48 INCHES, F-E2

    MDR report key: 5517455 · Received March 18, 2016

    Report

    Report Number
    MW5061096
    Event Type
    Other
    Date Received
    March 18, 2016
    Date of Event
    March 15, 2016
    Report Date
    March 18, 2016
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    IKT
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT HAD A BIFRONTAL CRANIOTOMY FOR TUMOR RESECTION WITH INTRAOPERATIVE MRI IMAGING AND INTRAOPERATIVE NEUROPHYSIOLOGIC MONITORING INCLUDING SSEPS AND MEPS. THE MRI WAS DONE WITH THE PLATINUM ELECTRODES IN PLACE. WHEN THE SURGICAL DRAPES WERE REMOVED BURNS WERE NOTED AT THE SITE OF THE EVOKED POTENTIAL ELECTRODES ON THE FOREHEAD AND BILATERAL CHEST. THERE WERE 2-4MM AREAS WHERE THE SKIN AROUND THE ELECTRODE APPEARED BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167016 GENUINE GRASS PLATINUM SUBDERMAL, 48 INCHES, F-E2 PLATINUM SUBDERMAL NEEDLE ELECTRODE IKT NATUS MANUFACTURING LIMITED F-E2 38471

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR