BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 6332398 · Received February 15, 2017

    Report

    Report Number
    2023988-2017-00021
    Event Type
    Injury
    Date Received
    February 15, 2017
    Date of Event
    January 20, 2017
    Report Date
    January 23, 2017
    Manufacturer
    INTEGRA NEUROSCIENCES CA/USA
    Product Code
    GWM
    PMA / PMN Number
    K102875
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 16FEB2017: THERE WAS NO INCREASE IN ANESTHESIA TIME. THEY PLACED A NEW CATHETER AND THE PATIENT WAS CHECKED IN CT. THE ONLY RISK TO THE PATIENT WAS THAT ICP WAS NOT FOLLOWED DUE TO THE "MISS" OF AN ICP CATHETER.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON APRIL 4, 2017. THE REPORTED CUSTOMER COMPLAINT THAT THE ¿ICP REDUCED BELOW ZERO¿ COULD NOT BE CONFIRMED. VISUAL INSPECTION OF THE RETURNED CATHETER INDICATED THAT IT IS POSSIBLE THAT THE CATHETER WAS NOT SECURED WITHIN THE BOLT ¿ THIS WAS EVIDENT FROM THE LACK OF AN INDENTATION MARK ON THE TEFLON TUBING TYPICAL OF A CATHETER THAT IS PROPERLY SECURED IN A BOLT ASSEMBLY. THE CATHETER WAS TESTED FOR FUNCTIONALITY AND MET ALL FUNCTIONAL TEST CRITERIA. THE CATHETER WAS THEN TESTED FOR DRIFT/STABILITY AND MET ALL STABILITY TEST CRITERIA. THE REPORTED CUSTOMER COMPLAINT COULD NOT BE DUPLICATED AND THE CATHETER MET ALL FUNCTIONAL TEST REQUIREMENTS THEREFORE THE ROOT CAUSE OF THIS ISSUE COULD NOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    THIS REPORT IS IN REGARDS TO THE SECOND CATHETER. THE CATHETER WAS IMPLANTED AND THE INTRACRANIAL PRESSURE (ICP) DECREASED BELOW 0. THIS FIRST CATHETER WAS THROWN. ANOTHER INTEGRA CATHETER WAS IMPLANTED (THIS SECOND CATHETER IS AVAILABLE TO BE RETURNED). ICP ALSO DECREASED BELOW 0. THE LOWEST MEASUREMENT WAS -15MMHG. A COMPETITOR CATHETER WAS IMPLANTED (SOPHYSA) AND GAVE THE RIGHT MEASUREMENTS. DELAY OF MONITORING WAS REPORTED TO BE 3 HOURS. AT THE TECHNICAL SITE IT WAS REPORTED THAT THEY PLACED THIS SET TO THE MONITOR. THE CATHETER GAVE -3 TO -2 AS A ZERO IN OPEN AIR. SINCE THEN, THERE WAS NO REAL ZERO CHANGES ANYMORE. THE CUSTOMER ALSO REPORTED THAT WHEN THEY WERE TAPPING THE CONNECTOR, THE VALUE READING CHANGED. IT COULD BE DUE TO POTENTIOMETER ISSUE IN THE CONNECTOR. LINKED TO MFG. REPORT NUMBER: 2023988-2017-00020, 2023988-2017-00022, 3006697299-2017-00027, 3006697299-2017-00028

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116751 OLM INTRACRANIAL PRESSURE MONITORING KIT N/A GWM INTEGRA NEUROSCIENCES CA/USA 111E00271571

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention