BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 1963704 · Received December 21, 2010

    Report

    Report Number
    2023988-2010-00048
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 15, 2010
    Report Date
    December 21, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES SD
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    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

    AN OLM INTRACRANIAL PRESSURE MONITORING KIT WAS INVOLVED IN AN INCIDENT AND WAS DESCRIBED AS FOLLOWS: THE "DERIVATION" OF THE INTRACRANIAL PRESSURE IS OVER 10MMHG (IN LESS THAN 12 HOURS) COMPARED WITH THE VALUE GIVEN BY THE EXTERNAL VENTRICULAR "DERIVATION." THE PRODUCT WAS IN CONTACT WITH THE PATIENT AND THE PATIENT WAS NOT INJURED. IT IS NOT KNOWN IF THE EVENT LED TO AN INCREASE IN SURGERY TIME. ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLM INTRACRANIAL PRESSURE MONITORING KIT NA GWM INTEGRA NEUROSCIENCES SD 305000172643

    Patients

    Seq Age Sex Outcome Treatment
    1