BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 3687746 · Received March 3, 2014

    Report

    Report Number
    2023988-2014-00009
    Event Type
    Injury
    Date Received
    March 3, 2014
    Report Date
    February 11, 2014
    Manufacturer
    INTEGRA NEURO SCIENCES
    Product Code
    GWM
    PMA / PMN Number
    853864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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

    ICP OLM CATHETER (1104B) BOLT BROKE LEAVING METAL THREAD IN THE PATIENT. THE EVENT WAS DESCRIBED AS FOLLOWS: AFTER DRILLING, THE NEURO SURGEON ALLOWED THE RESIDENT TO INSERT THE BOLT INTO THE BUR HOLE. AS SHE WAS TIGHTENING THE BOLT, THE BOLT BROKE, LEAVING THE METAL THREAD IN THE PATIENT'S HEAD. THE PHYSICIAN HAD TO DRILL AROUND THE BROKEN BOLT IN ORDER TO REMOVE THE METAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127916 OLM INTRACRANIAL PRESSURE MONITORING KIT NA GWM INTEGRA NEURO SCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention