BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM-ECLIPSE® CONTROLLER

    MDR report key: 7734266 · Received July 31, 2018

    Report

    Report Number
    1030489-2018-01079
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Date of Event
    June 22, 2018
    Report Date
    October 4, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    GWF
    PMA / PMN Number
    K050798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND THAT THE DEVICE CAME IN WITH A DAQ B CONNECTION FAILURE AND THE CONNECTORS WERE SHORTED. THE DEVICE WAS DISASSEMBLED, CLEANED, REPLACED DEFECTIVE CONNECTOR PCBA, UPGRADED THE DEVICE IN ACCORDANCE WITH DESIGN SPECIFICATIONS, REASSEMBLED, AND PLACED INTO THE BURN-IN CHAMBER TO CHECK FOR ANY HEAT RELATED FAILURES. THE DEVICE TESTED MET ALL MANUFACTURING SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE CONTROLLER DID NOT RUN THE DAQ CALIBRATION, THERE WERE NO IMPEDANCE READINGS, AND THE DEVICE WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577255 NIM-ECLIPSE® CONTROLLER STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC SOFAMOR DANEK USA, INC 945ECLC 0912088F

    Patients

    Seq Age Sex Outcome Treatment
    1