BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 2619654 · Received June 13, 2012

    Report

    Report Number
    2023988-2012-00022
    Event Type
    Malfunction
    Date Received
    June 13, 2012
    Report Date
    June 13, 2012
    Manufacturer
    INTEGRA NEURO SCIENCES CA/USA
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A1104B OLM INTRACRANIAL PRESSURE MONITORING PROBE WAS BEING USED ON A PT. THE PT WAS TAKEN FOR AN MRI WITH THIS PROBE (MISUSE). CONSEQUENTLY THE PROBE WAS BROKEN AND IT WAS NECESSARY TO INSERT A NEW ONE. THE PT WAS NOT INJURED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLM INTRACRANIAL PRESSURE MONITORING KIT NA GWM INTEGRA NEURO SCIENCES CA/USA

    Patients

    Seq Age Sex Outcome Treatment
    1