BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRACRANIAL PRESSURE/TEMPERATURE MONITORING K

    MDR report key: 2319867 · Received October 28, 2011

    Report

    Report Number
    2023988-2011-00040
    Event Type
    Death
    Date Received
    October 28, 2011
    Report Date
    October 28, 2011
    Manufacturer
    INTEGRA SAN DIEGO
    Product Code
    GWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON (B)(6) 2011 THAT THE INSERTION OF THE CATHETER WAS GOOD. HOWEVER, THE CUSTOMER WAS NOT ABLE TO READ THE TEMPERATURE DURING THE MONITORING. ANOTHER CATHETER WAS USED INSTEAD TO MONITOR THE TEMPERATURE. THE PRODUCT WAS IN CONTACT WITH THE PT, HOWEVER, THERE WAS NO PT INJURY OR DEATH ALLEGED. THE EVENT DID NOT INCREASE THE SURGERY TIME. ADD'L INFO WAS THEN RECEIVED ON (B)(6) 2011 WITH THE FOLLOWING INFO: THERE WAS NO PT INJURY OR DEATH ALLEGED WHEN THE COMPLAINT WAS INITIALLY REPORTED ON (B)(6) 2011. THE CATHETER WAS WORKING FINE AND THEN THERE WAS A PROBLEM WITH IT SO IT WAS REPLACED WITH ANOTHER CATHETER. THE TIME LOST BETWEEN CHANGING THE ORIGINAL CATHETER TO THE REPLACEMENT CATHETER COULD NOT BE DETERMINED. ON (B)(6) 2011, IT WAS REPORTED THAT "BRAIN DEATH" OCCURRED. THE PT DIED APPROX THREE WEEKS AFTER THE DEVICE ISSUE. ADD'L CLINICAL INFO HAS BEEN REQUESTED BUT NO NEW CLINICAL INFO HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRACRANIAL PRESSURE/TEMPERATURE MONITORING K NA GWM INTEGRA SAN DIEGO 305000212729

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death