BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM® 3.0 MAINFRAME INTERNATIONAL

    MDR report key: 18824706 · Received March 4, 2024

    Report

    Report Number
    1045254-2024-00307
    Event Type
    Injury
    Date Received
    March 4, 2024
    Date of Event
    January 30, 2024
    Report Date
    October 29, 2024
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00643169230392
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL SAFETY HAS ASSESSED THE EVENT, THIS EVENT AND ITS SEVERITY ARE KNOWN AND LABELED PER RMR113-1 AND INSTRUCTIONS FOR USE M988679A001 A. H3: ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8253200, SERIAL/LOT #: (B)(6) AND UDI#: (B)(4). H3: ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. H4: DEVICE MANUFACTURED DATE: 2015-06-26. H6: FDD, FDR, FDC, FDM CODES ARE SAME AS PRODUCT ID: 8253002(S/N:(B)(6)). IMG CODE IS G02005. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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 · 0

    H3: PRODUCT ANALYSIS FOUND THE SOFTWARE VERSION 2.0.0.0 IS UP TO DATE. (GUI V2014.11.11.921, DSP V2014.2.12.833). THERE WAS A SMALL S CRATCH ON THE SCREEN. THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED. H6: PREVIOUSLY APPLIED CODES FDM B21, FDR C21, FDC D16 ARE NO LONGER APPLICABLE. ADDITIONAL CODES IMG G02030 IS NO LONGER APPLICABLE. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8253200, SERIAL/LOT #: (B)(6), AND UDI#: (B)(4). H3: PRODUCT ANALYSIS FOUND THE PATIENT INTERFACE WAS RECEIVED IN GOOD CONDITION AND NO FAULT WAS FOUND. H6: PREVIOUSLY APPLIED CODES FDM B21, FDR C21, FDC D16 ARE NO LONGER APPLICABLE. CODES FDM B01, FDR C19, FDC D14 ARE APPLICABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H6: PREVIOUSLY APPLIED CODE FDC D02 HAS BEEN CORRECTED. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8253200, SERIAL/LOT #: (B)(6), UBD: , UDI#: (B)(4)H6: PREVIOUSLY APPLIED CODE FDC D14 HAS BEEN CORRECTED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. . MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, NIM TESTED PRE-OPERATIVELY WITH THE TESTER PROVIDED BY MEDTRONIC. THE TEST WAS CONCLUSIVE, ALL PARAMETERS RESPOND OPTIMALLY, SO THE NIM WAS OPERATIONAL AND CAN BE USED FOR THYROID SURGERY. INSTALLATION OF THE PATIENT AND INTUBATION WITH THE MAC GRATH FOR THE CORRECT POSITIONING OF THE NIM EMG TUBE IN RELATION TO THE VOCAL CORDS, CONTROL OF THE ELECTRODES. THE LIGHTS WERE GREEN. PLACEMENT OF THE LOG BY THE SURGICAL TEAM AND THE ANESTHESIA TEAM, VERIFICATION OF THE POSITION OF THE EMG TUBE VIA THE CONTROL OF THE ELECTRODES, THE LIGHTS WERE ALWAYS GREEN AND THE DISPLAY OF THE DETAILS OF THE ELECTRODES INFORMED OF A POSITIONING ON THE RIGHT OR LEFT AT = 0.1 K. ON-SCREEN VERIFICATION OF THE BASIC PARAMETERS FOR THYROID SURGERY, I.E.: THRESHOLD AT 100 V AND STIMULATION AT 1 MA. BEGINNING OF SURGERY, PRESSURE PROBLEMS SEVERAL TIMES DURING THE SURGERY OF THE FIRST LOBE BECAUSE THE EMG TUBE BENDS, PASSAGE UNDER THE IADE FIELDS TO CHECK THE TUBE AND THESE PRESSURE PROBLEMS. THERE WAS VENTILATION ISSUE BECAUSE OF THE EMG TUBE. VISUAL DISCOVERY OF THE RECURRENT NERVE BY THE SURGEON AND STIMULATION OF THE RECURRENT NERVE BY THE NIM STIMULATION STYLET, NO RESPONSE BY THE NIM., INTRAOPERATIVE CONTROL OF THE ELECTRODES VIA THE CONTROL PANEL ON THE MONITORING MODE OF THE NIM. THE LIGHTS WERE ALWAYS GREEN. DURING LEFT-SIDED SURGERY, SEVERAL ATTEMPTS AT STYLUS STIMULATION REMAIN UNANSWERED DESPITE DELIVERY SIGNALED BY THE STIMULUS SOUND SIGNAL. END OF THE FIRST SIDE (LEFT SIDE), THE SURGICAL DRAPES ARE LIFTED FOR REPOSITIONING OF THE INTUBATION TUBE WITH THE ANESTHESIOLOGIST AND SURGEON USING THE MAC GRAPH. TESTING OF THE ELECTRODES BY THE CONTROL PANEL AND FIXATION OF THE TUBE, IT SHOULD BE NOTED THAT THE LIGHTS ALWAYS REMAINED GREEN DESPITE THE VISUAL OBSERVATION BY THE ANESTHESIA AND SURGERY TEAM THAT THE EMG TUBE TURNED AND THE CONTACT ELECTRODES LOWERED LOWER THAN THE STRINGS VOICE. BEGINNING OF THE SURGERY ON THE RIGHT SIDE, VISUAL DISCOVERY OF THE RECURRENT NERVE BY THE SURGEON AND SAME PROBLEM AS ON THE LEFT I.E. STIMULATION WITHOUT RESPONSE FROM THE NIM, RECONTROL OF THE ELECTRODES BY THE CONTROL PANEL, THE LIGHTS REMAIN GREEN, THE NIM DELIVERED 1.0 MA BY THE STYLUS WITHOUT RESPONSE FROM THE NIM TO THE STIMULATION. UPON AWAKENING AND EXTUBATION, A DYSPNEA DRAW IS NOTED BY THE ANESTHESIA TEAM AND A DYSPHONIA IS NOTED ON A FIBROSCOPY DONE BY THE SURGEON, DECISION OF THE MEDICAL TEAM TO PUT THE PATIENT BACK TO SLEEP AND PERFORM A TRACHEOSTOMY. THERE WAS A PROCEDURAL DELAY OF THIRTY MINUTES. GENERATOR TAKEN OUT OF THE OPERATING ROOM AND QUARANTINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696435 NIM® 3.0 MAINFRAME INTERNATIONAL STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253002 209846923 00643169230392

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other "SEE H11...."| "SEE H11...."| "SEE H11...."