BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 MAINFRAME

    MDR report key: 19916437 · Received August 6, 2024

    Report

    Report Number
    1045254-2024-01204
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 11, 2024
    Report Date
    September 3, 2024
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00643169871014
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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: 8253200RF, SERIAL/LOT #: (B)(6), UBD: , UDI#: (B)(4) H4: DEVICE MFG DATE: 05.12.2014 H6:FDM-B17 FDR-C20 FDC-D16 AND IMG-G02005 CODES ARE APPLICABLE. 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

    H6: CORRECTION: FDD CODE OF A110201 WAS NOT SUBMITTED IN PREVIOUS REPORT. PREVIOUSLY APPLIED FDC CODE D16 IS NO LONGER APPLICABLE. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8253200RF, SERIAL/LOT #: (B)(6)/209031521, UDI#: (B)(4). H6: CORRECTION: FDD CODE OF A110201 WAS NOT SUBMITTED IN PREVIOUS REPORT. PREVIOUSLY APPLIED FDC CODE D16 IS NO LONGER APPLICABLE. 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 ELECTRODE AND PROBE PLACEMENT PROCEDURE, NIM SYSTEM BECAME UNRESPONSIVE, FREEZING AND MADE EXCESSIVE NOISE. PROCEDURE WAS COMPLETED WITH REPORTED PRODUCTS. THERE WAS NO PATIENT INJURY OR IMPACT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED THAT USER WAS ABLE TO MONITOR WHEN IT WAS NOT MAKING NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1648123 NIM® 3.0 MAINFRAME STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253001RF 207914269 00643169871014

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female "SEE H11....".