BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPE (CONDUCTIVE PLASTIC ELECTRODE)

    MDR report key: 2595672 · Received May 24, 2012

    Report

    Report Number
    2595672
    Event Type
    Injury
    Date Received
    May 24, 2012
    Date of Event
    May 13, 2012
    Report Date
    May 24, 2012
    Manufacturer
    IVES EEG SOLUTIONS INC.
    Product Code
    GXY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT FROM OUR EPILEPSY MONITORING UNIT (EMU) RECEIVED A MRI SCAN OF THE HEAD, NECK, AND SPINE. THE PATIENT HAD A NUMBER OF SHORT EEG ELECTRODES ATTACHED TO THE HEAD AND ONE MORE ELECTRODE FROM THE EEG LEAD SET CONNECTED TO THE CHEST. THE CHEST LEAD IS USED FOR EKG MONITORING. THE EKG LEAD IS LONGER THAN THE EEG LEADS. THESE LEADS ARE ONLY CONNECTED TO THE EEG MONITORING EQUIPMENT WHEN THE PATIENT IS IN THE EMU. AFTER THE SCAN WAS COMPLETE THE NURSE NOTICED A BLISTERING BURN WOUND AT THE EKG ELECTRODE SITE. THE ELECTRODES USED WERE BELIEVED TO BE MR SAFE.======================MANUFACTURER RESPONSE FOR EEG LEAD SET, IVES (PER SITE REPORTER).======================THEY ARE NOW RECOMMENDING THAT THE EKG LEAD NOT BE USED DURING MR SCANS. THEY BELIEVE THAT THE LONGER LENGTH OF THIS LEAD ALLOWS FOR RF ENERGY FROM THE MR SYSTEM TO HEAT THE ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPE (CONDUCTIVE PLASTIC ELECTRODE) ELECTRODE SYSTEM, EEG GXY IVES EEG SOLUTIONS INC. CPE *

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Required Intervention NO OTHER THERAPIES