BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 6335401 · Received February 16, 2017

    Report

    Report Number
    2023988-2017-00022
    Event Type
    Injury
    Date Received
    February 16, 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 (B)(6) 2017. THE INVESTIGATION INCLUDED: METHODS: REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. SEVEN LOTS 1104B THAT SHIPPED TO THE CUSTOMER FROM (B)(6) 2016 TO (B)(6) 2017 MET ALL REQUIREMENTS BEFORE RELEASED TO FG. COMPLAINTS HISTORY; COMPLAINT HISTORY, MODEL 110-4XXX, FROM (B)(6) 2016 THROUGH (B)(6) 2017 REVIEWED; THERE WERE FOUR OTHER COMPLAINTS THAT ISSUED WITH COMPLAINT CODE PERF034, AND NONE OF THEM WAS CONFIRMED. CONCLUSION: PRODUCT WAS NOT RETURNED FOR EVALUATION, NO ROOT CAUSE COULD BE ESTABLISHED FOR THE FAILURE MODE DESCRIBED IN THE CUSTOMER COMPLAINT.

    Description of Event or Problem · 1

    THIS REPORT IS IN REGARDS TO THE FIRST CATHETER. THE CATHETER WAS IMPLANTED AND THE INTRACRANIAL PRESSURE (ICP) DECREASED BELOW 0. THIS FIRST CATHETER WAS THROWN OUT. 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 NUMBERS: 2023988-2017-00020, 2023988-2017-00021, 3006697299-2017-00027, 3006697299-2017-00028.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119660 OLM INTRACRANIAL PRESSURE MONITORING KIT N/A GWM INTEGRA NEUROSCIENCES CA/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention