BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPLETE BRAIN IMC PROBE KIT

    MDR report key: 494610 · Received November 11, 2003

    Report

    Report Number
    9617494-2003-00029
    Event Type
    Death
    Date Received
    November 11, 2003
    Report Date
    November 11, 2003
    Manufacturer
    GMS-GESSELLSCHAFT FUR MEDIZINISCHE
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NO RMA WAS ISSUED, THE DEVICE IS NOT EXPECTED TO BE RETURNED. THE EDUCATOR CALLED TO REPORT THAT A PT PRESENTED TO THE HOSPITAL COMATOSE AFTER AN ACUTE ISCHEMIC STROKE. PT WAS UNRESPONSIVE AND REQUIRED AN AIRWAY. THE NEUROSURGEON INSERTED A LICOX IM3.ST. THE NURSE REPORTED THE LICOX FUNCTIONED AS EXPECTED. THE NEUROSURGEON AND THE PULMONOLOGIST DISAGREED ON THE UTILITY OF THE LICOX NUMBERS. THE DEVICE WAS IN USE FOR TWO DAYS WITH THE OXYGEN READING OF AROUND 30 MMHG. THE LICOX NUMBERS RESPONDED WELL TO TREATMENT ACTIVITIES. THE PT REMAINED HYPERTENSIVE (180/100) AND THE PULMONOLOGIST WANTED TO LOWER BLOOD PRESSURE AGAINST THE NEUROSURGEON'S RECOMMENDATIONS. THE PULMONOLOGIST ORDERED LABETALOL IV, WHICH IMMEDIATELY DROPPED THE PT'S BLOOD PRESSURE TO (90-100 SYSTOLLIC). AT THAT TIME THE LICOX READINGS ALSO DROPPED TO APPROXIMATELY 12 MMHG. A BOLUS OF IV FLUID WAS ADMINISTERED AND PT'S BLOOD PRESSURE DID IMPROVE. THE PULMONOLOGIST ORDERED MORPHINE SULFATE FOR PAIN AGAINST THE NEUROLOGIST'S RECOMMENDATIONS. THE PT'S BLOOD PRESSURE DID NOT IMPROVE AND IV DOPAMINE WAS STARTED. WHEN THE PT'S MEAN ARTERIAL PRESSURE IMPROVED, THE LICOX NUMBERS ALSO IMPROVED AND THE NURSE REPORTED THE LICOX UNIT WAS "RIGHT ON THE MONEY." THE PT EXPERIENCED A GLASGOW COMA SCALE READING OF 4 AND THEN EXPIRED. THE PT HAD PRESENTED TO THE HOSPITAL IN POOR CONDITION WITH POOR OUTCOME EXPECTED. THE LICOX DEVICE FUNCTIONED AS INTENDED AND REPORTED VALUES CORRELATING TO THE CLINICAL CIRCUMSTANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE BRAIN IMC PROBE KIT BRAIN TISSUE OXYGEN MONITORING SYSTEM GWM GMS-GESSELLSCHAFT FUR MEDIZINISCHE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *