BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAINFRAME 8253001 NIM RESPONSE 3.0

    MDR report key: 2948580 · Received February 7, 2013

    Report

    Report Number
    1045254-2013-00076
    Event Type
    Injury
    Date Received
    February 7, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 10, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DOCTOR FEELS THERE IS NOTHING WRONG WITH THE DEVICE AND WILL NOT BE RETURNING IT. THE DEVICE WAS NOT RETURNED AND THEREFORE, NO EVALUATION COULD BE PERFORMED. METHOD: NOT AVAILABLE IN (B)(4). EVALUATION OF EVENT: THE DEVICE WAS NOT RETURNED. BASED ON THE REPORTED INFORMATION, THE "MOST LIKELY" CAUSE IS NERVE FATIGUE DURING THE CASE. PER THE NIM CAPITAL RISK MANAGEMENT REPORT (B)(4) REVISION 26: FALSE NEGATIVE (INCLUDING OVER STIMULATION) HAS BEEN ASSIGNED A SEVERITY OF 4 AND AN OCCURRENCE OF 2. SEVERITY 4 IS DEFINED AS "COULD RESULT IN PERMANENT IMPAIRMENT OR REQUIRES ADDITIONAL SURGICAL PROCEDURES." IN THIS EVENT, PATIENT IMPACT WAS REPORTED IN THE FORM OF VOCAL CORD PARALYSIS. THEREFORE, THERE IS NO INFORMATION TO SUGGEST THAT THE SEVERITY RANKINGS AS CURRENTLY REFLECTED IN THE RMR HAVE BEEN EXCEEDED. (B)(4). THEREFORE, THERE IS NO INFORMATION TO SUGGEST THAT THE OCCURRENCE RANKING AS CURRENTLY REFLECTED IN THE RMR HAS BEEN EXCEEDED. BASED ON THIS INVESTIGATION, THE SEVERITY/OCCURRENCE OF THIS EVENT IS NOT GREATER THAN EXPECTED PER THE RMR.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS A 6MM EMG CONTACT TUBE (B)(4). THE TUBE WAS DISCARDED BY THE FACILITY AND THEREFORE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A THYROIDECTOMY WAS PERFORMED ON A VERY SMALL PATIENT WITH A VERY SMALL TRACHEA. THE PATIENT HAD A VERY LARGE THYROID. THE DOCTOR SAID THAT HE THOUGHT HE WAS STIMULATING FINE BECAUSE HE STIMULATED THE NERVE AND HEARD THE RESPONSES. HE CONFIRMED THAT THEY CHECKED THE NERVE AND THAT THEY HEARD THE POSITIVE RESPONSES FROM THE NIM SYSTEM WHEN CHECKING THE NERVES. THEY HAD THE NIM SET TO THE FACTORY SETTINGS AS THEY NEVER ADJUST THAT. IT WAS BELIEVED TO BE AT 1.0 AND 100ML. THE EMG TUBE WAS LEFT IN THE PATIENT OVERNIGHT. THE NEXT DAY, WHEN THEY TOOK IT OUT THE PATIENT HAD A RASPY SOUNDING VOICE AND HER BREATHING WAS BAD. THE PATIENT ALSO WOKE UP WITH STRIDERS (PAINFUL SWALLOWING). THE DOCTOR PUT A SCOPE DOWN HER THROAT TO CHECK HER VOCAL CORDS AND FOUND THAT HER VOCAL CORDS WERE NOT MOVING AND SHE HAD AN ABNORMALLY LARGE AMOUNT OF SWELLING. THE DOCTOR IS CONCERNED THAT THE VOCAL CORDS ARE PARALYZED, BUT STATED HE FEELS IT IS TEMPORARY PARALYSIS. THE DOCTOR STATED THAT HE FEELS THAT THE NIM WAS WORKING PROPERLY AND HE DOES NOT WANT TO SEND IT IN FOR REPAIR OR EVALUATION. HE FEELS THAT THE SYSTEM SUCCESSFULLY IDENTIFIED THE NERVES CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52541 MAINFRAME 8253001 NIM RESPONSE 3.0 STIMULATOR, NERVE ETN MEDTRONIC, INC. 8253001 205747732

    Patients

    Seq Age Sex Outcome Treatment
    1 00033 YR Other 6MM EMG CONTACT TUBE 8229506