BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRICULAR TUNNEL.PRESSURE MONITORING KIT

    MDR report key: 509686 · Received January 13, 2004

    Report

    Report Number
    2023988-2004-00008
    Event Type
    Malfunction
    Date Received
    January 13, 2004
    Report Date
    January 12, 2004
    Manufacturer
    INTEGRA NEUROCARE LLC
    Product Code
    HCA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE CATHETER WAS ZEROED PRIOR TO INSERTION. THE CATHETER INITIALLY FUNCTIONED AS DESIRED, HOWEVER SOME HOURS LATER ERROR MESSAGE WERE DISPLAYED "E01, E06, AND E08". THE INTRACRANIAL PRESSURE MONITORING WAS DISCONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRICULAR TUNNEL.PRESSURE MONITORING KIT NEURO MONITORING HCA INTEGRA NEUROCARE LLC * V1403

    Patients

    Seq Age Sex Outcome Treatment
    1 *