BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM-ECLIPSE® CONTROLLER

    MDR report key: 21539636 · Received March 6, 2025

    Report

    Report Number
    1045254-2025-00750
    Event Type
    Malfunction
    Date Received
    March 6, 2025
    Date of Event
    December 6, 2022
    Report Date
    March 7, 2025
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00643169071872
    PMA / PMN Number
    K050798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF THE DEVICE FOUND THAT THE UNIT CAME WITH A CONNECTION FAILURE DUE TO BENT STIMULATOR PINS ON THE CONNECTOR PCBA. 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 DAQ B DOES NOT APPEAR TO BE RECOGNIZED. AN ERROR MESSAGE WAS DISPLAYED ABOUT DAQ B WHEN MODALITIES RECORDING FROM THAT BOX ARE TURNED ON. ADDITIONALLY, THE IMPEDANCE CHECK ONLY SHOWED GREY BOXES FOR PROGRAMMED INPUTS. THIS ISSUE WAS CONFIRMED WITH DIFFERENT CABLES, DAQ BOXES, AND CONTROLLERS. THE CONTROLLER WAS SWAPPED OUT TO COMPLETE THE CASE. THERE WAS NO KNOWN PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592816 NIM-ECLIPSE® CONTROLLER STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. 945ECLC 216061014 00643169071872

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown