BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 2852650 · Received November 27, 2012

    Report

    Report Number
    2023988-2012-00045
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    INTEGRA NEUROSCIENCES CA/USA
    Product Code
    GWM
    PMA / PMN Number
    K853864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AN OLM INTRACRANIAL PRESSURE MONITORING KIT (1104 B OR 1104 BT) WAS REPORTED TO HAVE A PROBLEM WHICH WAS DESCRIBED AS FOLLOWS; "5 DAYS AFTER THE INSERTION THE VALUE INDICATED WAS 80 MM HG. THIS VALUE DID NOT CHANGE WHEN UNSCREWING THE LOCKING SCREW OF THE BOLT. THE CUSTOMER DECIDED TO TAKE OFF THE PROBE AND INSERT ONE FROM CODMANN. THE CODMANN PROBE INDICATED A VALUE OF 20 MM HG." ON (B)(4) 2012 ADD'L INFO WAS RECEIVED. "PRODUCT IN CONTACT WITH PT, NO PT INJURY OR DEATH ALLEGED, THE EVENT DID NOT LEAD TO AN INCREASE OF SURGERY TIME. PRODUCT WAS THROWN." THE INITIAL REPORT INDICATED THAT THE UNIT INVOLVED WAS EITHER THE 1104 B OR 1104 BT. FOLLOWING A SEARCH AND BASED ON THE LAST TWO LOTS THAT WERE SENT TO THE FACILITY, IT WAS DETERMINED THAT THE PRODUCT INVOLVED WAS THE 1104B.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLM INTRACRANIAL PRESSURE MONITORING KIT NA GWM INTEGRA NEUROSCIENCES CA/USA 305000246460 OR 305000247717

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention