BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM 3.0 MAINFRAME

    MDR report key: 10712084 · Received October 21, 2020

    Report

    Report Number
    1045254-2020-00485
    Event Type
    Injury
    Date Received
    October 21, 2020
    Date of Event
    February 1, 2020
    Report Date
    November 25, 2020
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00613994499714
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H2: PRODUCT ANALYSIS OF MAINFRAME FOUND THAT THE TOUCHSCREEN NEEDS TO BE CALIBRATED. PRODUCT ANALYSIS OF PATIENT INTERFACE FOUND THAT BOTH CLIPS AND WAVE WASHER WERE BENT. H6: FDR C070601 APPLIES TO PATIENT INTERFACE ONLY. 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.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 853200, SERIAL/LOT #: (B)(4), UDI#: (B)(4). PRODUCT ANALYSIS OF MAINFRAME FOUND THAT SOFTWARE NEEDS TO BE UPGRADED TO NEWER VERSION. UNIT WAS FAILING IN DYNAMIC RANGE TEST AND INTERMITTENTLY IN SELF TEST, MAIN BOARD NEEDS TO BE REPLACED TO CORRECT BOTH FAILURES. PRODUCT ANALYSIS OF PATIENT INTERFACE FOUND THAT BOTH CLIPS WERE LOOSE. FDR 4203 AND 3208 APPLY TO MAINFRAME ONLY AND FDR 180 APPLIES TO PATIENT INTERFACE ONLY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE BIOMED DEPARTMENT THAT THERE WAS A PATIENT INJURY DURING A NERVE MONITORED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178206 NIM 3.0 MAINFRAME STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253001 205705809 00613994499714

    Patients

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