BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRIX TRUE TECH

    MDR report key: 510234 · Received January 13, 2004

    Report

    Report Number
    2023988-2004-00007
    Event Type
    Malfunction
    Date Received
    January 13, 2004
    Date of Event
    December 10, 2003
    Report Date
    January 12, 2004
    Manufacturer
    INTEGRA NEUROCARE LLC
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED THIS DEVICE IN 2003. THIS CATHETER WAS INSERTED INTO THE PT OVERNIGHT IN 2003. CUSTOMER STATES THAT THE CATHETER WORKED FINE 5 DAYS LATER. THE INTRACRANIAL PRESSURE MONITOR SHOWED INCREASED SIGNS OF INTRACRANIAL PRESSURE INTO THE 50'S. THE CUSTOMER NOTICED A DAMPENED WAVEFORM SO THEY PUT A FLUID COUPLER ON THE LINE TO TRY AND CORRELATE ICP READINGS. THE CUSTOMER COULD NOT GET A GOOD READING OF THE FLUID COUPLER. THE PT WAS TREATED FOR ELEVATED SIGNS OF ICP AND CT SCAN AND REVEALED A FAIR AMOUNT OF BLOOD AROUND THE CATHETER TIP. THE CUSTOMER DECIDED TO PLACE ANOTHER VENDORS ICP CATHETER AND ONCE IT WAS PLACED THE READINGS WERE IN THE NORMAL RANGE. THE VENTRIX CATHETER WAS PULLED FROM THE PT AND THE CUSTOMER STATES THEY DID NOT NOTICE A BLOOD CLOT AROUND THE TIP OF THE CATHETER. THE CUSTOMER BELIEVES THE BLOOD CLOT MAY HAVE CAUSED THE ELEVATED READINGS, BUT WAS CONCERNED ABOUT THE ACCURACY OF THE CATHETER. THE CATHETER WILL NOT BE RETURNED FOR EVAL SINCE THE CUSTOMER DISCARDED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRIX TRUE TECH NEURO MONITORING GWM INTEGRA NEUROCARE LLC * W049184

    Patients

    Seq Age Sex Outcome Treatment
    1 *