BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXON ECLIPSE CONTROLLER

    MDR report key: 2974119 · Received February 19, 2013

    Report

    Report Number
    1045254-2013-00121
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Report Date
    November 27, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    GWF
    PMA / PMN Number
    K061639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING EVAL, TESTING/REPAIR FOUND THAT THE DEVICE FAILED THE REVERSE CURRENT TEST WHICH WAS CAUSED BY THE STIMULATION BOARD FAILURE. THE MFR DATE IS UNOBTAINABLE. RECORDS PRIOR TO SEPT 2011 REMAIN WITH THE ORIGINAL DEVICE MFR. THE NIM-ECLIPSE SYSTEM NEUROVASCULAR WORKSTATION IS INTENDED FOR USE TO MONITOR SENSORY AND MOTOR PATHWAYS. IF THE SYSTEM FAILS TO PERFORM AS INTENDED, (ESPECIALLY TO EFFECT OR DETECT ELECTROMYOGRAPHIC (EMG) ACTIVITY) IT PRESENTS THE POTENTIAL FOR TEMPORARY OR PERMANENT DAMAGE TO THE NERVE THAT IS PRESENT. THE ECLC ECLIPSE SYSTEM CONTROLLER PROVIDES HIGH SPEED DIGITAL DATA PROCESSING, STIMULATION GENERATION AND AUDIO PROCESSING OF EMG ACTIVITY AND ALSO SUPPLIES SWITCHED AC POWER TO THE COMPUTER. THE CONTROLLER CONNECTS TO THE COMPUTER VIA THE HIGH SPEED PCMCIA INTERFACE. WHEN INFO SUGGESTS THAT THE NIM ECLIPSE EQUIPMENT HAD THE POTENTIAL TO NOT STIMULATE TO AFFECT ELECTROMYOGRAPHY (EMG), OR TO DETECT EMG, IT IS ASSUMED THAT THE FAILURE WAS DEVICE-RELATED AND MAY HAVE GONE UNDETECTED. IN THIS CASE, THERE IS NO INFO TO SUGGEST AN EVENT COULD NOT BE INTERPRETED FALSELY - THE REPORT IS INCONCLUSIVE AS TO THE CAUSE OF FIELD OBSERVATION. THEREFORE, WITHOUT INFO TO REASONABLY SUGGEST SERIOUS INJURY, OR THAT MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE SEROUS INJURY, WE ARE FILING THIS REPORT AS A PRODUCT PROBLEM. THIS PRODUCT IS BEING USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    THE MFR HAS REFINED THE CRITERIA FOR MAKING MDR DECISIONS. UPON A RETROSPECTIVE REVIEW, THE FOLLOWING EVENT IS NOW BELIEVED TO BE REPORTABLE: A CUSTOMER RETURNED AN ECLIPSE CONTROLLER STATING "EVAL REQUESTED." THERE WAS NO SUGGESTION OF PT INJURY OR INVOLVEMENT. TESTING/REPAIR FOUND A FAILED STIMULATION BOARD. A FAILED STIMULATION BOARD HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PT INJURY (LOSS OF STIMULATION DURING USE LEADING TO A FALSE NEGATIVE) - AS A SUDDEN FAILURE IS NOT CONSISTENTLY ACCOMPANIED BY WARNING/ERROR MESSAGES DURING A PROCEDURE. AT THIS TIME WE ARE UNABLE TO CONFIRM WHETHER THE CUSTOMER RECEIVED ANY ERROR MESSAGES OR ALERTS OF THE FAULT. THIS REPORTED EVENT HAS NO REFERENCE TO AN ALARM OR WARNING, THEREFORE, IT MUST BE ASSUMED THAT AN ALARM OR WARNING WENT UNDETECTED OR DID NOT OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72456 AXON ECLIPSE CONTROLLER GWF MEDTRONIC XOMED, INC. 945ECLC NI

    Patients

    Seq Age Sex Outcome Treatment
    1