BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRACRANIAL PRESSURE/TEMPERATURE MONITORING K

    MDR report key: 2386326 · Received December 19, 2011

    Report

    Report Number
    2023988-2011-00060
    Event Type
    Injury
    Date Received
    December 19, 2011
    Report Date
    December 19, 2011
    Manufacturer
    INTEGRA NEUROSCIENCES CA/USA
    Product Code
    GWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED 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 INVOLVING THE 1104BT: INTRACRANIAL PRESSURE/TEMPERATURE MONITORING KIT (SAME PATIENT, PRODUCT CATALOG NUMBER, AND USER FACILITY). THIS REPORT IS IN REGARDS TO THE SECOND 1104BT CATHETER. IT WAS REPORTED THAT THE FIRST CATHETER USED WAS ZEROED AND PLACED WITH GOOD WAVEFORMS. THE INTRACRANIAL PRESSURE (ICP) WAS ABOUT 15. THEN, THE ICP READINGS WENT TO THE NEGATIVE NUMBERS WITHIN A FEW HOURS. THE ICP READINGS THEN WENT TO THE POSITIVE NUMBERS. THE CLINICIAN REPORTED THAT THE ICP READINGS DID NOT MATCH THE CLINICAL CONDITION OF THE PATIENT. IT WAS THOUGHT THAT THE PATIENT SHOULD HAVE A HIGH ICP READING. THE FIRST CATHETER WAS REMOVED, DISCARDED, AND REPLACED WITH A SECOND 1104BT CATHETER. THE SECOND CATHETER HAD THE SAME PROBLEMS AND RESULTS AS THE FIRST CATHETER. THIS SECOND CATHETER WAS REMOVED. THE PATIENT THEN WENT TO SURGERY AND IT WAS REPORTED THAT THE PATIENT'S ICP SHOULD HAVE BEEN HIGHER THAT WHAT IT WAS. A THIRD ICP WAS PLACED IN THE RIGHT FRONTAL LOBE AND THERE WAS NO ISSUES REPORTED WITH THE THIRD CATHETER. ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED. CROSS REFERENCED TO MANUFACTURER REPORT NUMBER 2023988-2011-00059.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRACRANIAL PRESSURE/TEMPERATURE MONITORING K NA GWM INTEGRA NEUROSCIENCES CA/USA 305000226736

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention