BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 INTERFACE

    MDR report key: 18361674 · Received December 20, 2023

    Report

    Report Number
    1045254-2023-01125
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Date of Event
    November 24, 2023
    Report Date
    December 20, 2023
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00643169782440
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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: 8253002, SERIAL/LOT #: (B)(6), UDI#: (B)(4). H3: ANALYSIS OF PRODUCT:8253200 FOUND THAT CUSTOMER COMPLAINT CAN BE CONFIRMED. THERE WAS PROBLEM IN CHANNEL 1 STIM 1. FAILURE IN PCB. WORN WAVE WASHER AND LOOSE CLAMPS. ANALYSIS OF PRODUCT ID: 8253002 NO ANOMALIES FOUND. CUSTOMER COMPLAINT CANNOT BE CONFIRMED. H4: MANUFACTURING DATE FOR PRODUCT ID 8253002 IS 2018-01-25. H6: FDR- C19, FDC- D14 ARE FOR PRODUCT ID 8253002. ADDITIONAL CODE: G02030 IS FOR PRODUCT ID 8253002. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTRA-OP, START OF CASE EVERYTHING WAS OK, AFTER A PERIOD OF TIME NO RESPONSE TO NERVE PROBE WHEN IN CONTACT WITH TISSUE OR NERVE. PROBE REPLACED AND RE TESTED , STILL NO RESPONSE TO PROBE. ALL ELECTRODE CONNECTIONS TICKED OK. SWAPPED NERVE INTEGRITY MONITOR WITH ANOTHER DEVICE AND COMPLETED CASE. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2118173 NIM® 3.0 INTERFACE STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253200 213106178 00643169782440

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown "SEE H10...."