BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO VENTRICULAR BOLT 110-4HMT

    MDR report key: 508755 · Received January 9, 2004

    Report

    Report Number
    2023988-2004-00006
    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

    THE USER FACILITY REPORTED TO THE DISTRIBUTOR IT WAS IMPOSSIBLE TO ZERO BALANCE THE CATHETER PRIOR TO USE. THE VALUE DID NOT GO DOWN BELOW 28MMHG. IT IS UNKNOWN IF THE DEVICE WAS USED ON THE PT. 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 * W043029-AB

    Patients

    Seq Age Sex Outcome Treatment
    1 *