BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTROLLER ECLC ECLIPSE

    MDR report key: 3830798 · Received May 23, 2014

    Report

    Report Number
    1045254-2014-00120
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    March 17, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    PMA / PMN Number
    K061639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT DEVICES: AMPLIFIER: 945DAQ916; DIG PREAMPLIFIER: 510K: K050798, SERIAL # (B)(4). PREAMPLIFIER: DAQ916 DIGITAL: 510K: K061639, SERIAL # (B)(4). (B)(4). THE PRODUCT ANALYSIS IS STILL IN PROGRESS AT THIS TIME. RESULTS: RESULTS PENDING COMPLETION OF EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    NEW INFORMATION WAS OBTAINED FROM THE COMPLAINANT. THE CASE WAS CANCELLED BEFORE THE PATIENT WAS ANESTHETIZED, INDICATING THAT THERE WAS NO PATIENT INVOLVEMENT IN THE DEVICE MALFUNCTION. (B)(4). THE PRODUCT ANALYSIS FOR CONTROLLER (B)(4) NEEDS REPLACING. THERE IS NO STIMULATION. THE STIM BOARD ((B)(4)) WAS REPLACED. THE PRODUCT IS UPDATED TO CURRENT DESIGN SPECIFICATIONS. THE CONNECTOR BOARD WAS REPLACED. THE ITEM WAS TESTED AND PASSED MANUFACTURING SPECIFICATIONS.¿ THE PRODUCT ANALYSIS FOR AMPLIFIER (B)(4) DIG PREAMPLIFIER INDICATES THAT VARIOUS COMPONENTS REQUIRED UPGRADE, INCLUDING SCREWS, THE MOUNTING CHAIN, GASKETS, AND PANELS. THE ITEM WAS UPGRADED TO CURRENT DESIGN SPECIFICATIONS AND PASSED INSPECTION. THE PRODUCT ANALYSIS FOR PREAMPLIFIER (B)(4) DIGITAL INDICATES, ¿THE CONNECTOR IN THE BOTTOM BOARD ((B)(4)) WAS BENT. THE BOARD WAS REPLACED. THE ITEM WAS TESTED AND PASSED MANUFACTURING SPECIFICATIONS.¿ RESULTS: ELECTRICAL PROBLEM. CONCLUSION: DEVICE REPAIRED AND RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ECLIPSE "STOPPED WORKING DURING A LIVE CASE. NEEDS TO BE CHECKED." FOLLOW-UP QUESTIONS REGARDING EVENT DETAILS FOUND THAT THE USER STATES THERE WERE NO VISUAL OR AUDIBLE INDICATORS, AND NO BASELINE. THE CASE WAS RESCHEDULED, BUT IT IS NOT KNOWN AT THIS TIME IF THE PATIENT WAS IN FACT ALREADY UNDER ANESTHESIA OR NOT, AS THE INITIAL REPORT STATED THAT THE EVENT HAPPENED "DURING A LIVE CASE", AND FOLLOW-UP STATED THAT THERE WAS NO BASELINE PRESENT. WITH THIS INFORMATION IN CONFLICT, MEDTRONIC MUST CONSERVATIVELY ASSUME THAT THE PATIENT WAS UNDER ANESTHESIA AND AFTER WORKING PROPERLY, THE DEVICE STOPPED WORKING.

    Description of Event or Problem · 1

    NEW INFORMATION WAS OBTAINED FROM THE COMPLAINANT. THE CASE WAS CANCELLED BEFORE THE PATIENT WAS ANESTHETIZED, INDICATING THAT THERE WAS NO PATIENT INVOLVEMENT IN THE DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307341 CONTROLLER ECLC ECLIPSE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. ECLC 205828937

    Patients

    Seq Age Sex Outcome Treatment
    1