BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAMINO ICP MONITORING CATHETER W/INTEGRATED LIC

    MDR report key: 3954674 · Received July 18, 2014

    Report

    Report Number
    2023988-2014-00031
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 26, 2014
    Manufacturer
    INTEGRA NEUROSCIENCES CA/USA
    Product Code
    GWM
    PMA / PMN Number
    K102875
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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

    IT WAS REPORTED THAT DURING THE SURGERY, THE CATHETER INDICATED UNUSUAL VALUES VIA THE MONITOR (UP TO 90 INTRACRANIAL PRESSURE (ICP). ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2014 FROM THE CUSTOMER WITH THE FOLLOWING A (B)(6) YEAR OLD MALE PATIENT HAD AN UNDERLYING CONDITION OF TRAUMATIC BRAIN INJURY (TBI). DATE OF THE EVENT WAS ON (B)(6) 2014. THE DEVICE WAS IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT INJURY AND THE EVENT DID NOT LEAD TO AN INCREASE IN SURGERY TIME. THE MEDICAL STAFF REMOVED THE CATHETER AND REPLACED IT. THE NEW CATHETER WAS WORKING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423117 CAMINO ICP MONITORING CATHETER W/INTEGRATED LIC NA GWM INTEGRA NEUROSCIENCES CA/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention