BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 6139519 · Received December 1, 2016

    Report

    Report Number
    1226348-2016-10827
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    GWM
    PMA / PMN Number
    K914479
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SENSOR WAS RETURNED AND EVALUATED. A REVIEW OF QUALITY RECORDS FOUND THAT THE DEVICE MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO DISTRIBUTION. EVALUATION OF THE RETURNED DEVICE FOUND THAT THE CATHETER MATERIAL WAS SEVERELY STRETCHED AND INTERNAL WIRES WERE BROKEN INSIDE THE CATHETER. DUE TO THE CONDITION OF THE DEVICE AS IT WAS RECEIVED, NO FURTHER FUNCTIONAL TESTING WAS POSSIBLE. THE SUPPLIER WAS ABLE TO CONFIRM THE REPORTED ISSUE AND DETERMINED THE CAUSE OF FAILURE TO BE MISHANDLING OF THE CATHETER. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    INSERTION OF MICROSENSOR. AFTER SEVERAL DAYS OF USE WITHOUT ISSUE, MICROSENSOR GIVES READING OF ELEVATED ICP, THEN WITHIN AN HOUR, DROPS BELOW 0 TO READ -6. AFTER TROUBLESHOOTING, IT IS DETERMINED THAT THE SENSOR IS STILL WORKING PROPERLY AND MONITORING RESUMES. MONDAY MORNING (TODAY), I AM TOLD THAT THEY HAVE REMOVED THE MICROSENSOR AND PATIENT IS EXTUBATED. THEY DISCOVER THE MICROSENSOR SHEATHING IS TORN IN SEVERAL PLACES AND WHEN COMPARED TO ANOTHER MICROSENSOR OF THE SAME PART NUMBER, LOOKS TO BE 1 FOOT LONGER. INVESTIGATION IS UNDERWAY AND MORE INFORMATION IS BEING COLLECTED TO DETERMINE HOW THIS OCCURRED, AND WILL REPORT BACK IF ANY MORE INFORMATION IS DISCOVERED. REGARDLESS, PATIENT TREATMENT PLAN WAS NOT AFFECTED. THEY PROCEEDED AS NORMAL, EVEN AFTER READINGS MIGHT HAVE BEEN INACCURATE AS THEY DETERMINED THE ICP MICROSENSOR MOST LIKELY WAS PULLED OUT OF POSITION WHILE PATIENT UNDERWENT CT SCAN. SO, THEY ARE CONFIDENT ICP SENSOR WAS WORKING PROPERLY UNTIL THIS POINT OF MALPOSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789019 NEUROMONITOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. / MEDOS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1