BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM-ECLIPSE® CONTROLLER

    MDR report key: 5295210 · Received December 14, 2015

    Report

    Report Number
    1045254-2015-00426
    Event Type
    Malfunction
    Date Received
    December 14, 2015
    Date of Event
    November 12, 2015
    Report Date
    November 19, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION WAS RECEIVED ON FEBRUARY 5, 2016. AFTER FEW HOURS OF USE, THE USER WAS ALERTED TO THE ISSUE BY THE NIM ECLIPSE COMPUTER NOTEBOOK ¿DISPLAYS A SIGN INDICATING THAT THERE¿S NO COMMUNICATION¿ WITH THE NIM ECLIPSE CONTROLLER. ONCE THE USER CLICKS THE ¿ACCEPT BUTTON¿ TO BYPASS THE SYSTEM ALERT, ¿THE SIGN CONTINUE APPEARING AFTER SOME MINUTES¿¿THE NIM ECLIPSE COMPUTER NOTEBOOK ¿DOESN¿T WORK CORRECTLY¿ AND THE ¿SYSTEM BECOMES SLOW.¿

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: (1) COMPUTER NOTEBOOK SPANISH (NCCPU-ES); SN: (B)(4); LOT: 207628791; DATE OF MANUFACTURE: OCTOBER 23, 2013; 510K: K061639. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT ANALYSES WERE COMPLETED ON APRIL 8, 2016. BOTH DEVICES WERE THOROUGHLY TESTED AND BOTH PERFORMED TO SPECIFICATION. THE PROBLEM DESCRIBED BY THE CUSTOMER COULD NOT BE REPLICATED. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NIM ECLIPSE CONTROLLER AND NOTEBOOK "NEEDS REPAIR" AND THIS WAS DISCOVERED DURING USE. THIS IS THE ONLY INFORMATION PROVIDED AND THERE WAS ALSO NO REPORT OF PATIENT IMPACT OR INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823684 NIM-ECLIPSE® CONTROLLER STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. ECLC 207558508

    Patients

    Seq Age Sex Outcome Treatment
    1