BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 INTERFACE

    MDR report key: 21462833 · Received February 25, 2025

    Report

    Report Number
    1045254-2025-00604
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    February 17, 2023
    Report Date
    February 26, 2025
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    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

    H3: PRODUCT ANALYSIS OF THE DEVICE CONCLUDED THAT THE REPORTED FAULT WAS NOT CONFIRMED HOWEVER THE CLIPS WERE LOOSE AND THE WAVE WASHERS WERE WORN. 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: PRODUCT ANALYSIS FOR PRODUCT ID: 8253002, SERIAL/LOT#: (B)(6) FOUND THAT THE REPORTED ISSUE WAS NO CONFIRMED HOWEVER THE KNOBS ON THE DEVICE TURN VERY STIFF, THE POTS ON THE TOUCHSCREEN PCB ARE WORN AND THE TOUCHSCREEN WAS SCRATCHED. ADDITIONAL CODES OF IMG G02005, IMG G0204004 AND IMG G04079 ARE APPLICABLE FOR PRODUCT ID: 8253002, SERIAL/LOT#: (B)(6). THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA: 624392. 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 INTRA-OP, THE NIM SYSTEM WAS NOT WORKING PROPERLY, MAKING A LOT OF UNNECESSARY NOISES, AND NOT STIMULATING PROPERLY. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341175 NIM® 3.0 INTERFACE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. 8253200

    Patients

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