BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM-ECLIPSE® PREAMPLIFIER

    MDR report key: 21076698 · Received January 5, 2025

    Report

    Report Number
    1045254-2025-00019
    Event Type
    Malfunction
    Date Received
    January 5, 2025
    Date of Event
    December 12, 2024
    Report Date
    January 6, 2025
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00643169378476
    PMA / PMN Number
    K050798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS FOUND NO FAULT IN THE DEVICE. 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 SETUP DAQ BOX DOES NOT RESPONSE. USER REPLACED THE DAQ BOX WITH BACKUP UNIT. THERE WAS NO ASSOCIATED PATIENT SYMPTOMS OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950477 NIM-ECLIPSE® PREAMPLIFIER STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. DAQ916 212226831 00643169378476

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown