BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXON ECLIPSE INTRAOPERATIVE NEUROMONITOR 32 CHANNEL

    MDR report key: 2195367 · Received August 2, 2011

    Report

    Report Number
    MW5021616
    Event Type
    Injury
    Date Received
    August 2, 2011
    Date of Event
    July 8, 2011
    Report Date
    August 2, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    GWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    I WAS REMOTE INTRAOPERATIVELY MONITORING THE PT FOR A LEFT CAROTID ENDARTERECTOMY, WITH EEG AND (B)(6), VIA A MEDTRONIC ECLIPSE 32 CHANNEL MONITORING DEVICE. IN THE COURSE OF MONITORING, THE EEG TRACES WERE SEEN TO INTERMITTENTLY FLATTEN. DESPITE INTERVENTIONS WITH THE ANESTHESIA STAFF, THESE PATTERNS INDICATIVE OF EITHER HIGH ANESTHESIA OR LOW BLOOD FLOW (CEREBRAL ISCHEMIA) PERSISTED AND JUST AT THE MOMENT OF CROSS-CLAMPING TO PERFORM THE PROCEDURE. I RECOMMENDED THAT A SHUNT BE PLACED. THE SURGEON PERFORMED THE SHUNT PLACEMENT, BUT THERE WAS NO IMPROVEMENT IN THE FLATTENED EEG. AS IT TURNED OUT, THE FLATTENING WAS ERRONEOUS INFO PRODUCED BY THE SOFTWARE. THE SOFTWARE IS FLAWED (MEDTRONIC HAS ACKNOWLEDGED THIS THROUGH THEIR STAFF). WHEN DATA IS TRANSMITTED OUT OF THE OPERATING ROOM VIA A SLOWER BROADBAND CONNECTION, THE DATA LAG CAUSES THE SOFTWARE TO SHUT DOWN THE EEG DISPLAY FOR SOME REASON. THIS PRODUCES AN ERRONEOUS DISPLAY THAT CAN CAUSE, AS IN THIS CASE, A RECOMMENDATION TO BE MADE FOR SHUNTING WHEN IT IS NOT NECESSARY. THUS THE PT IN THIS CASE WAS UNNECESSARILY SUBJECTED TO A SHUNT WITH ITS MANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXON ECLIPSE INTRAOPERATIVE NEUROMONITOR 32 CHANNEL NEUROMONITOR GWM MEDTRONIC ECLIPSE APPLIES TO ALL

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| O| S