BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 2509154 · Received March 27, 2012

    Report

    Report Number
    2023988-2012-00015
    Event Type
    Malfunction
    Date Received
    March 27, 2012
    Date of Event
    December 29, 2011
    Report Date
    March 27, 2012
    Manufacturer
    INTEGRA NEUROSCIENCES CA/USA
    Product Code
    GWM
    PMA / PMN Number
    K853864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS (SAME PATIENT, SAME USER FACILITY, SIMILAR DEVICE). THIS REPORT IS IN REFERENCE TO THE 1104B (OLM INTRACRANIAL PRESSURE MONITORING KIT). IT WAS REPORTED THAT WHEN THE SURGEON INSERTED THE 1104B (OLM INTRACRANIAL PRESSURE MONITORING KIT) DURING A DECOMPRESSIVE SURGERY, IT DID NOT MEASURE PRESSURE. THE SURGEON THEN USED A 1104BT (INTRACRANIAL PRESSURE / TEMPERATURE MONITORING KIT) FROM THE FACILITY'S STOCK BUT IT ALSO DID NOT MEASURE PRESSURE. THE STAFF TESTED BOTH CATHETERS AND FOUND THE 1104B DEFECTIVE BUT 110-4BT SEEMED NORMAL. THERE WAS NO PATIENT INJURY. PATIENT CONDITION WAS REPORTED AS "NO CHANGE". 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 CA/USA 3050RX194061

    Patients

    Seq Age Sex Outcome Treatment
    1