BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM® 3.0 MAINFRAME

    MDR report key: 5876398 · Received August 15, 2016

    Report

    Report Number
    1045254-2016-00261
    Event Type
    Injury
    Date Received
    August 15, 2016
    Date of Event
    July 21, 2016
    Report Date
    July 21, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: - 8253200RF: PATIENT INTFC 8253200RF, RESP 3.0 REFURB, S/N (B)(4), LOT 7190900, MANUFACTURED DATE: UNKNOWN - 8220325: MUTING PROBE 8220325. NIM MANUFACTURED DATE UNKNOWN - 8229708: EMG TUBE 8229708 NIM TRIVANTAGE 8.0MM ID, LOT 0211153644. INITIAL USE OF THE TUBE. MANUFACTURED 04/20/2016, USE BEFORE 04/19/2020. THE 510K: K112686, ETN. PRODUCT EVALUATION: - 8253001, MAINFRAME: SERVICE AND REPAIR EXAMINED THE UNIT AND COULD NOT DUPLICATE CUSTOMER¿S ISSUE. PLACED THE UNIT INTO BURN-IN FOR 24 HOURS FOR OBSERVATION. AFTER BURN-IN, UNIT CHANNEL 3 FAILED DYNAMIC RANGE AND EMG AMPLIFIER STABILITY TESTS. REPLACED MAIN BOARD AND P/I ADAPTER BOARD DUE TO FAILURE. PLACED UNIT BACK TO BURN-IN. THE ITEM WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. - 8253200RF, PATIENT INTERFACE: SERVICE AND REPAIR EXAMINED THE UNIT AND COULD NOT DUPLICATE CUSTOMER¿S ISSUE. REPLACED WAVE WASHERS DUE TO LOOSE CABLE CLIP. THE ITEM WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THYROID CASE, THE PATIENT WAS INTUBATED WITH A NIM TRIVANTAGE EMG TUBE AND A NIM 3.0 WAS BEING USED FOR THE PROCEDURE. THE STARTUP SCREEN SHOWED ALL GREEN CHECKS, SO THEY PROCEEDED TO THE MONITORING SCREEN. THE DOCTOR DID A TAP-TEST TO SEE IF ALL WAS CONNECTED AND RECEIVED THE EXPECTED RESPONSE. WITHIN THE NEXT 45 SECONDS THE MONITOR STARTED GIVING OFF A STRANGE TONE, A "MONITORING" TONE, EVERY 15 SECONDS. SHE CONFIRMED THAT THE SOUND WAS VERY CYCLICAL, ABOUT EVERY 15 SECONDS. THERE WERE WAVEFORMS AT THE BOTTOM OF THE SCREEN THAT LOOKED LIKE ARTIFACT. THE THRESHOLD WAS AT 100, THEN THEY TRIED MOVING TO 150 AND THEN 175, WITH NO HELP. SHE ALSO TRIED CHANGING THE STIMULUS REJECTION FROM 2.1 TO 2.6, WITH NO SUCCESS. THEY PROCEEDED THROUGH TROUBLESHOOTING, BUT THE ISSUE WAS NOT RESOLVED. THEY DECIDED TO USE ANOTHER NIM SYSTEM INSTEAD, HOWEVER, AFTER CONNECTING AND HOOKING THAT SYSTEM UP THE SAME THING OCCURRED, SO THE DOCTOR DECIDED TO CANCEL THE CASE. IT WAS CONFIRMED THAT BY THE ANESTHESIOLOGIST THAT THEY DID USE A LONG-TERM PARALYZING AGENT, BUT THAT IT WAS USED MUCH EARLIER AND HAD WORN OFF BY THIS TIME. THERE WAS NO PATIENT INJURY; AT THIS TIME, THE CASE HAS NOT BEEN RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528246 NIM® 3.0 MAINFRAME STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253001 67114900

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other