BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM® 3.0 INTERFACE

    MDR report key: 13235220 · Received January 12, 2022

    Report

    Report Number
    1045254-2022-00020
    Event Type
    Injury
    Date Received
    January 12, 2022
    Date of Event
    December 15, 2021
    Report Date
    March 15, 2022
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00643169782440
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3:ANALYSIS FOUND DURING INSPECTION THE DEVICE WORKS NORMALLY BUT THERE WERE SOME VISUAL DEVIATIONS FOUND. ONE ASSEMBLY CLIP IS LOOSE. THE WAVE WASHER IS WORN. THE SPARE FUSES ARE MISSING. THE MAIN FUSES ARE NOT AS DESCRIBED BY THE MANUFACTURER. H6: ANNEX E E2403, ANNEX B B17, ANNEX C C20, ANNEX D D14, ANNEX F F26 ARE NO LONGER VALID. THIS IS SAME EVENT AS REGULATORY REPORT #1045254-2022-00024, WHERE THE MAINFRAME IS ALSO USED. PRODUCT ID: 8253002, SERIAL#: (B)(6), LOT#: 218204457, UBD:, UDI#:(B)(4). 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

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

    Description of Event or Problem · 0

    THE RECURRENT LARYNGEAL NERVE INJURY TO PATIENT IN THYROIDECTOMY PROCEDURE DUE TO THE LACK OF MONITORIZATION AS NO SOUND, WHEN STIMULATED AND NOT RESOLVED EVEN AFTER THE TUBE REPOSITION DURING THE SURGERY. ALSO AUDIBLE INDICATOR DOES NOT ALERT THIS ISSUE WHEN STIMULATED. THE SURGEON BELIEVE THAT A COMPONENT, OR COMPONENTS, OF THE NIM SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT OUTCOME AS THE DEVICE DOES NOT ALERTED THE PRESENCE OF NERVE. THE WAVEFORM WAS NOT SHOWING ON THE MONITOR WHEN STIMULATING THE NERVE. THE TRACHEOSTOMY SURGICAL INTERVENTION WAS PERFORMED TO RESOLVE THE PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE WAS NOT WORKING PROPERLY. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732060 NIM® 3.0 INTERFACE STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253200 218470283 00643169782440

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown