BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 3850980 · Received February 12, 2014

    Report

    Report Number
    2023988-2014-00004
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Report Date
    January 20, 2014
    Manufacturer
    INTEGRA NEUROSCIENCES CA/USA
    Product Code
    GWM
    PMA / PMN Number
    K853864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    OLM INTRACRANIAL PRESSURE MONITORING KIT; CATHETER WAS NOT WORKING WHICH REQUIRED A REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93122 OLM INTRACRANIAL PRESSURE MONITORING KIT NA GWM INTEGRA NEUROSCIENCES CA/USA 3050RY255145

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention