BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTROLLER ECLC ECLIPSE

    MDR report key: 3786691 · Received May 2, 2014

    Report

    Report Number
    1045254-2014-00096
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    PMA / PMN Number
    K061639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. METHOD ¿ NO TESTING METHODS PERFORMED. RESULTS ¿ NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION ¿ DEVICE NOT RETURNED. (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

    IT WAS REPORTED THAT THE CONTROLLER DEVICE USB CONNECTOR WAS LOOSE RESULTING IN SLOW DATA TRANSFER RESULTING IN A DELAY IN THE PROCEDURE. THE PROCEDURE WAS FOR THE REMOVAL OF GROWING RODS AND INSERTION OF DEFINITIVE INSTRUMENTATION FOR SCOLIOSIS. REPORTEDLY, THE DAY OF SURGERY THE MACHINE PASSED SYSTEM SELF-CHECK PREOPERATIVE TESTING. PATIENT WAS CONNECTED WITH ELECTRODES WITH INITIAL ELECTRODE IMPEDANCE PERFORMANCE FUNCTIONING PROPERLY. DATA ACQUISITION FOR LOWER LIMB SEP BASELINE AND MEP BASELINE WERE CONFIRMED BUT THERE WAS HESITATION IN THE SYSTEM WITH TRAIN OF FOUR RUN. TRYING TO RUN UPPER LIMB SEP THE SYSTEM WAS ACQUIRING 15-20 SWEEPS THEN LOSING THE DATA (BUILDING AVERAGE). MACHINE SOFTWARE WAS CLOSED AND RE-STARTED, BUT THE PROBLEMS CONTINUED AND IT WAS IMPOSSIBLE TO ACQUIRE ANY SEP DATA, MEP STIMULATION WAS DELAYED (I.E. PRESS THE STIM BUTTON THEN NOTHING HAPPENS FOR 5 SECONDS), CHANGING SETS TOOK 10 + SECONDS. I WAS UNABLE TO ACQUIRE ENOUGH DATA TO SET BASELINES. SURGEON WAS INFORMED AND DECIDED TO CONTINUE WITH REMOVAL OF OLD GROWING ROD INSTRUMENTATION BUT DELAY THE REMAINDER OF THE SURGERY. THERE WAS NO REPORT OF PATIENT INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264133 CONTROLLER ECLC ECLIPSE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. ECLC 206464917

    Patients

    Seq Age Sex Outcome Treatment
    1 00014 YR Required Intervention