BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO VENTRICULAR BOLT 110-4HMT

    MDR report key: 508772 · Received January 9, 2004

    Report

    Report Number
    2023988-2004-00002
    Event Type
    Malfunction
    Date Received
    January 9, 2004
    Report Date
    January 7, 2004
    Manufacturer
    INTEGRA NEUROCARE LLC
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER ZERO BALANCING, THE CATHETER WAS PLACED AND CONNECTED TO A V420 MONITOR. ONE DAY POST INSERTION, IT BECAME IMPOSSIBLE TO MEASURE INTRACRANIAL PRESSURE. THE CATHETER WAS REPLACED, INTRACRANIAL PRESSURE MONITORING WAS THEN SUCCESSFUL. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO VENTRICULAR BOLT 110-4HMT NEURO MONITORING GWM INTEGRA NEUROCARE LLC * W046017

    Patients

    Seq Age Sex Outcome Treatment
    1 *