BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM 4.0 CONSOLE

    MDR report key: 19283728 · Received May 10, 2024

    Report

    Report Number
    1045254-2024-00698
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    March 1, 2024
    Report Date
    June 6, 2024
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00763000395896
    PMA / PMN Number
    K200759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS #804942290:10-MAY-2024,AS12- SERVICE REPORT ATTACHED. 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NIM4CPB1, SERIAL/LOT #: (B)(6), UBD: , UDI#: (B)(4) H3: PRODUCT ANALYSIS: CONSOLE (S.NO: C2214105) NO FAULT WAS FOUND IN THE DEVICE. IMDRF CODES: IMG G02030, FDD A090803, FDR C19, FDC D14 <(>&<)> FDM B01 PRODUCT ANALYSIS: PATIENT INTERFACE (S.NO: (B)(6)) NO FAULT WAS FOUND IN THE DEVICE. AS A PRECAUTIONARY MEASURE, THE AFE PCBA WAS REPLACED. IMDRF CODES: FDD A090803, IMG G02005 ,FDR C19, FDC D14 <(>&<)> FDM B01. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PROCEDURE THERE WAS NO NERVE REACTION. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION OBTAINED STATING THAT DURING TOTAL NECK THYROID PROCEDURE USING TRIVANTAGE TUBE AND PRASS PROBE AND WAS STEMMING A NERVE THEY WERE GETTING A POSITIVE TONE BUT NO WAVE FORM. JUST A STRAIGHT LINE ACROSS. THE DOCTOR NOTICED IT AND USED THE NIM 3.0 AND WHEN THEY USED THE 3.0 AND IT DISPLAYED THE WAVE FORMS AND GAVE A POSITIVE TONE. THEY STIMULATED THE THYROID AFTER THE NECK DISSECTION. THEY WERE USING THE DEFAULT THYROID PROCEDURE CASE. NONE OF THE DISPOSABLES WERE CHANGED. THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PROCEDURE IN NIM CONSOLE THERE WAS NO NERVE REACTION. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2307892 NIM 4.0 CONSOLE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. NIM4CM01 225510507 00763000395896

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown "SEE H11...."