BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASCADE ELITE

    MDR report key: 3752923 · Received March 21, 2014

    Report

    Report Number
    3752923
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    December 2, 2013
    Report Date
    March 21, 2014
    Manufacturer
    CADWELL LABORATORIES, INC.
    Product Code
    GWE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    INTRAOPERATIVE MONITORING TECHNICIANS OBSERVED DIFFERENCES IN THE RESPONSES (MORPHOLOGY) OF THE LEFT UPPER EXTREMITY AS COMPARED TO THE RIGHT UPPER EXTREMITY. SPECIFICALLY, THE LEFT UPPER RESPONSE LATENCY WAS 2.5MS EARLIER WITH REDUCED AMPLITUDE AND THE PERIPHERAL (ERB) HAD MINOR PEAK PRECEDING THE ASSUMED ACTUAL RESPONSE. THE TECHNICIANS REMOVED THE ES-IX STIMULATOR FROM USE REPLACING IT WITH THE ES-5-100 STIMULATOR. THE PROGRAM WAS RESET WITH THE SAME STIMULATION PARAMETERS AND MONITORING RESUMED. THE RESPONSES IN QUESTION THEN HAD HIGHER AMPLITUDE, SLOWER RESPONSE LATENCY, AND THE PERIPHERAL (ERB) WAS WITHOUT THE MINOR PEAK. THE RESPONSES NOW CORRELATED WITH THE LEFT SIDE.TECHNICIAN'S FURTHER EXPLANATION: A SIMPLIFIED DESCRIPTION IS THAT THE PATIENT'S "BASELINE" SENSORY AND/OR MOTOR RESPONSES ARE RECORDED JUST PRIOR TO SURGERY. ALL ACQUIRED RESPONSES FROM THAT POINT ON ARE REFERENCED TO THE BASELINE. CHANGES IN THE RESPONSE CAN OCCUR FROM MANY INFLUENCES, ANESTHESIA, TEMPERATURE, THE POSITION OF A LIMB, OR THE ACTUAL SURGICAL PROCEDURE. IF THERE IS ANY CHANGE IN THE RESPONSE THE IOM TECHNICIAN NEEDS TO DETERMINE THE CAUSE. IF THESE INFLUENCES ARE RULED OUT AND CANNOT BE ATTRIBUTED TO CAUSES OTHER THAN THE SURGICAL PROCEDURE THE TECHNICIAN WILL NOTIFY THE SURGEON OF THE CHANGE. THE SURGEON THEN DECIDES HOW TO PROCEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168521 CASCADE ELITE STIMULATOR, PHOTIC, EVOKED RESPONSE GWE CADWELL LABORATORIES, INC. 12 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR