BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 510958 · Received January 14, 2004

    Report

    Report Number
    2023988-2004-00009
    Event Type
    Malfunction
    Date Received
    January 14, 2004
    Report Date
    January 14, 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

    THE DISTRIBUTOR RECEIVED NOTIFICATION FROM THE USER FACILITY THAT THE CATHETER WAS PLACED AND FUNCTIONED AS DESIRED UPON INSERTION. A FEW HOURS POST INSERTION, THE MONITOR DISPLAYED A READING OF OVER 30, WHICH DID NOT CORRELATE WITH THE PT. THE TREATING PHYSICIAN REMOVED THE CATHETER FROM THE PT, ZEROED THE CATHETER AND RE-INSERTED. FOR A WHILE THE MONITOR DISPLAYED ADEQUATE VALUES BUT ON THE FOLLOWING DAY OF MONITORING THE READING DISPLAYED -20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRACRANIAL PRESSURE MONITORING KIT NEURO MONITORING GWM INTEGRA NEUROCARE LLC * W049125

    Patients

    Seq Age Sex Outcome Treatment
    1 *