BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 2199144 · Received July 14, 2011

    Report

    Report Number
    2023988-2011-00019
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    INTEGRA, SAN DIEGO
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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

    AN OLM INTRACRANIAL MONITORING KIT WAS INVOLVED IN AN INCIDENT WHICH WAS DESCRIBED AS FOLLOWS: WHEN THE PHYSICIAN WAS PLACING AN INTRACRANIAL PRESSURE (ICP) MONITORING BOLT, THE ICP READING ON THE MPM WOULD INCREASE IF THE BOLT WAS TIGHTENED. (140 THEN CAME DOWN TO 70). THE READING WOULD DROP TO 14, WHEN THE BOLT WAS LOOSENED, WHICH WAS CONSISTENT WITH WHAT WAS EXPECTED BASED ON PT'S CONDITION. ADDITIONAL CLINICAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLM INTRACRANIAL PRESSURE MONITORING KIT NA GWM INTEGRA, SAN DIEGO 3050RY200486

    Patients

    Seq Age Sex Outcome Treatment
    1