BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 4092858 · Received August 21, 2014

    Report

    Report Number
    2023988-2014-00041
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Report Date
    July 29, 2014
    Manufacturer
    INTEGRA NEUROSCIENCES CA/USA
    Product Code
    GWM
    PMA / PMN Number
    K102875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS EXPECTED TO BE RETURNED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS (SAME PATIENT, SAME INCIDENT, SIMILAR PROBLEMS, SAME PRODUCT ID, DIFFERENT SERIAL NUMBERS). THIS REPORT IS REGARDS TO THE SECOND CATHETER USED. LINKED TO MFR REPORT NUMBER: 2023988-2014-00040. THE FIRST CATHETER WAS INSERTED AND IT DISPLAYED INTRACRANIAL PRESSURE (ICP) FOR ABOUT 3 HOURS AND THEN THE READINGS DISAPPEARED. IT WAS REPLACED AND THE SECOND CATHETER ALSO DISPLAYED ICP FOR ABOUT 3 HOURS AND LATER STOPPED DISPLAYING THE VALUES. WHEN THE SECOND CATHETER WAS TAKEN OUT, THE CATHETER WAS ALSO BENT. IT WAS BENT AT THE DISTAL END OF THE CATHETER. THERE WAS NO PATIENT INJURY OR DEATH ALLEGED. THE DISTRIBUTOR WILL TRY TO GET PRODUCT DETAILS REGARDING THE FIRST CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504511 OLM INTRACRANIAL PRESSURE MONITORING KIT NA GWM INTEGRA NEUROSCIENCES CA/USA 305000295382

    Patients

    Seq Age Sex Outcome Treatment
    1