BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM 4.0 CONSOLE

    MDR report key: 19674946 · Received July 4, 2024

    Report

    Report Number
    1045254-2024-01001
    Event Type
    Malfunction
    Date Received
    July 4, 2024
    Date of Event
    June 10, 2024
    Report Date
    August 8, 2024
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00763000395896
    PMA / PMN Number
    K200759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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: NIM4CM01 (S/N: (B)(6)) APPLICABLE CODES: FDD A070803 A0908, FDR C21, FDC D16, FDM B21 IMG G02030 PRODUCT ID: NIM4CPB1 (S/N:(B)(6)) APPLICABLE CODES: FDD A070803 A0908, FDR C21, FDC D16, FDM B21 IMG G02005 MANUFACTURING DATE FOR NIM4CPB1 (S/N:(B)(6).): (B)(6)2022. H3: ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. 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

    H3: PRODUCT ANALYSIS VERIFIED NOT WORKING PROPERLY. SLOW BOOT UP. UNIT PRESENTED WITH SOFTWARE UPDATE V1.4.3. UPDATED SOFTWARE TO V.1.5.4 VIA SSD- V1.5.4. CORRECTED THE SLOW BOOT UP. G02030 ARE NO LONGER VALID. PRODUCT ID: NIM4CPB1 (S/N: (B)(6) PRODUCT ANALYSIS VERIFIED NOT WORKING PROPERLY. DEVICE ALSO HAD MISSING PARTS AND WOULD NOT UPDATE SOFTWARE. REPLACED MISSING PART ALSO REPLACED MAIN BOARD AND UPDATED SOFTWARE TO V. 1.5.4. H6: PREVIOUS 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 THE DEVICE WAS WORKING INCONSISTENTLY AND TAKES SLOW TO POWER ON. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270558 NIM 4.0 CONSOLE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. NIM4CM01 224961108 00763000395896

    Patients

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