BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM 4.0 CONSOLE

    MDR report key: 20310418 · Received September 26, 2024

    Report

    Report Number
    1045254-2024-01614
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    August 19, 2021
    Report Date
    September 26, 2024
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00763000395896
    PMA / PMN Number
    K200759
    Removal / Correction Number
    Z-2409-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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). PRODUCT ID: NIM4CPB1, SERIAL/LOT #: (B)(6) WAS RETURNED AND DEVICE ANALYSIS CONCLUDED THAT THE CLIPS WERE BROKEN. H6: CODES OF FDD A051203, FDM B01 AND FDR C070603 ARE APPLICABLE FOR PRODUCT ID: NIM4CPB1, SERIAL/LOT #: (B)(6). PREVIOUSLY APPLIED CODE OF FDC D16 IS NO LONGER APPLICABLE. ADDITIONAL CODE OF IMG G02005 AND IMG G0405204 ARE APPLICABLE FOR PRODUCT ID: NIM4CPB1, SERIAL/LOT #: (B)(6). THIS REPORT IS BEING SUBMITTED AS PART OF REMEDIATION ACTIVITIES ASSOCIATED WITH CAPA # 643143, WHICH IS ADDRESSING MDR REPORTING GU IDANCE FROM FDAS 1995 PREAMBLE, WHICH ENSURES COMPLAINTS RELATED TO CORRECTIONS AND RECALLS WHICH WERE PREVIOUSLY REPORTED TO FDA UNDER 21 CFR 806 ARE NOW REPORTED AS MDRS ; THIS IS NOT A NEW MALFUNCTION/EVENT. 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 DURING THE LEFT PARTIAL THYROID PROCEDURE, THE PATIENT INTERFACE WAS REPORTED TO BE DAMAGED AFTER IT WAS DROPPED. THE BACK CLIP BROKE OFF, AND VOCALIS 1 COULD NOT PASS THE ELECTRODE CHECK. SINCE STIMULATION WAS FUNCTIONING, IT WAS DECIDED THAT THE TUBE NOT BE RE-INTUBATED TO THE PATIENT. AS A RESULT, THE PROCEDURE WAS EXTENDED BY LESS THAN ONE HOUR. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2238761 NIM 4.0 CONSOLE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. NIM4CM01 221577470 00763000395896

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female "SEE H11...."