BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM 4.0 CONSOLE

    MDR report key: 20393725 · Received October 8, 2024

    Report

    Report Number
    1045254-2024-01727
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    September 11, 2024
    Report Date
    December 1, 2024
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00763000002978
    PMA / PMN Number
    K200759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS UPDATED 1. PRODUCT ANALYSIS: CONSOLE (S.NO: C1915186) PRODUCT ANALYSIS STATED VERIFIED NOT WORKING BENT/MISSING EIC PCBA KNOBS AND A PMB PCBA CABLE CONNECTOR VOLTAGE FAILURE. IMDRF CODES: FDD A0908, IMG G02030, G04034 & G04079, FDR C070601, C0201, FDC D02 & FDM B01. 2. PRODUCT ANALYSIS: PATIENT INTERFACE (S.NO: P2026964) PRODUCT ANALYSIS STATED NO ABNORMALITIES WERE FOUND IN DEVICE. IMDRF CODES: FDD A0908, IMG G02005, FDR C20, FDC D20 & FDM B01. 3. PRODUCT ANALYSIS: PATIENT INTERFACE (S.NO: P2026990) PRODUCT ANALYSIS STATED DEFECTIVE MAIN PCBA CABLE CONNECTION PORT. IMDRF CODES: FDD A0908, IMG G04034, FDR C0201, FDC D02 & 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: N IM4CPB1, SERIAL/LOT #: (B)(6), UDI#: (B)(4) ; PRODUCT ID: NIM4CPB1, SERIAL/LOT #: (B)(6), UDI#: (B)(4). CONSOLE (B)(6) IMDRF CODES: IMG G02030, FDD A0908, FDR C20, FDC D02 & FDM B17 2. PATIENT INTERFACE (B)(6) IMDRF CODES: FDD A0908, IMG G02005 , FDR C20, FDC D20 & FDM B17. 3. PATIENT INTERFACE (B)(6) IMDRF CODES: FDD A0908, IMG G02005 , FDR C20, FDC D20 &FDM B17. 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 TESTING NIM CONSOLE WIRELESS WAS WORKING BUT NOT WIRED. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283944 NIM 4.0 CONSOLE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. NIM4CM01 220216243 00763000002978

    Patients

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