BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAINFRAM 8253001 NIM RESPONSE 3.0

    MDR report key: 1489954 · Received October 1, 2009

    Report

    Report Number
    1045254-2009-00043
    Event Type
    Other
    Date Received
    October 1, 2009
    Date of Event
    September 1, 2009
    Report Date
    September 1, 2009
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    GWF
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDWATCH FORM WAS NOT RECEIVED FROM THE REPORTER, THEREFORE, ANY MISSING OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER DESPITE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION. THIS PRODUCT WAS NOT BEING USED FOR DIAGNOSIS. A MEDTRONIC SALES MANAGER PERFORMED IN-HOUSE DEMONSTRATION AND TRAINING WITH THIS DOCTOR IN 2009, AND ANOTHER DOCTOR HAD USED THE SAME UNIT A FEW DAYS EARLIER WITH NO PROBLEMS. THE PRODUCT EVALUATION BY MEDTRONIC CONFIRMED PROPER FUNCTION OF THE PRODUCT. VISUAL INSPECTION SHOWED NO DAMAGE OR DEFECTS. ELECTRICAL AND FUNCTIONAL INSPECTION SHOWED THE HARDWARE AND CIRCUITRY WAS WORKING PROPERLY AND WITHIN SPECIFICATION. THE UNIT HAS BEEN RUN THROUGH ALL MANUFACTURING CHECKS TO DOCUMENT THE IN-SPECIFICATION CONDITION. THE CUSTOMER STATES THAT THE NIM SYSTEM ACCESSORIES WERE TESTED AND FUNCTIONED PROPERLY.

    Description of Event or Problem · 1

    DURING A THYROID CASE, IT WAS REPORTED THAT THE DOCTOR WAS ON A NERVE, THE NERVE WAS VISUALIZED, AND THE UNIT DID NOT SIGNAL. THE DOCTOR SWITCHED THE PROBE AND THE UNIT STILL DID NOT READ NERVE ACTIVITY. THE DOCTORS STATED THAT THEY DO NOT FEEL THERE WAS A PROBLEM OR DEFECT WITH THE NIM, THOUGH THE UNIT DID NOT RESPOND, AND THAT THE LACK OF RESPONSE MAY HAVE BEEN DUE TO NERVE FATIGUE. THIS EVENT RESULTED IN BILATERAL VOCAL CHORD PARALYSIS FROM NERVE DAMAGE AND POST-OP TROUBLE BREATHING. BASED ON THEIR MEDICAL ASSESSMENT OF THE PATIENT AND THE EVENT, THE DOCTOR SAYS THAT THE PATIENT IS IMPROVING AND, IN TIME, HE EXPECTS A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAINFRAM 8253001 NIM RESPONSE 3.0 GWF - STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED, INC. 8253001 63157800

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other