BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTROLLER 945ECLC ECLIPSE

    MDR report key: 3778451 · Received April 29, 2014

    Report

    Report Number
    1045254-2014-00095
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Report Date
    April 4, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    PMA / PMN Number
    K050798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE PRODUCT ANALYSIS DETERMINED THAT THE STIMULATION BOARD FAILED THE STIM POLARITY TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT WAS RETURNED FOR PREVENTATIVE MAINTENANCE. THE SERVICE REPORT STATES, "THE STIM BOARD (ASSY-2524-003) WAS REPLACED DUE TO THE UNIT FAILING THE STIM POLARITY TEST." A FAILED ASSY-2524 BOARD THAT IS UNDETECTED COULD LEAD TO A FALSE NEGATIVE RESPONSE. THERE WAS NO REPORTED PATIENT INVOLVEMENT, BUT IT IS NOT KNOWN WHETHER THE USER WAS ALERTED TO THIS FAILURE, AS THE DEVICE WAS SIMPLY SENT IN FOR PREVENTATIVE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257516 CONTROLLER 945ECLC ECLIPSE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. 945ECLC

    Patients

    Seq Age Sex Outcome Treatment
    1