BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1X U

    MDR report key: 1067533 · Received June 25, 2008

    Report

    Report Number
    2023988-2008-00020
    Event Type
    Malfunction
    Date Received
    June 25, 2008
    Date of Event
    May 31, 2008
    Report Date
    June 25, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES
    Product Code
    GWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORTER STATED THAT A NEUROSENSOR PROBE WAS PLACED IN A PATIENT WHO HAD A SUBARACHNOID HEMORRHAGE FROM A RUPTURED POSTERIOR INFERIOR CEREBELLAR ARTERY ANEURYSM. THE PATIENT HAD ADDITIONAL DEVICES THROUGH WHICH ICP (INTRACRANIAL PRESSURE), PBTO2 (BRAIN TISSUE OXYGENATION) AND TEMPERATURE WERE BEING MONITORED. THE NEUROSENSOR PROBE SHOWED CBF (CEREBRAL BLOOD FLOW) READINGS IN THE 20'S AND ICP VALUES RANGING FROM 3-10 MMHG. THE ICP READING FROM ANOTHER ACCESS DEVICE RANGED FROM 16-26MM HG. THE NEUROSENSOR PROBE WAS PLACED TO A DEPTH OF 25MM. THE DEVICE'S CABLE WAS DISCONNECTED FROM THE NEUROSENSOR WHEN THE PATIENT WAS TAKEN TO THE OPERATING ROOM. A PROCEDURE FOR CLIPPING OF AN ANEURYSM WAS UNSUCCESSFUL DUE TO CEREBRAL EDEMA. UPON RETURN FROM THE OPERATING ROOM IT WAS NOTED THAT WIRES FROM THE WHITE CABLE OF THE DEVICE TO THE HUB WHICH CONNECTS IT TO THE NEUROSENSOR WERE STRIPPED. THE REPORTER STATED THAT EVEN A GENTLE TWIST ON THE BLUE RING CAUSES THE CABLE TO DISENGAGE FROM THE CONNECTOR. CBF WAS BRIEFLY CALIBRATED TO THE BEDSIDE MONITOR, BUT CALIBRATION WAS EVENTUALLY LOST AND COULD NOT BE RE-OBTAINED. ICP COULD NOT BE CALIBRATED TO THE BEDSIDE MONITOR THE DECISION WAS MADE TO INSERT A SECOND PROBE. A REQUEST HAS BEEN MADE TO THE REPORTER FOR MORE CLINICAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1X U NEUROLOGICAL DIAGNOSTIC DEVICE GWM INTEGRA NEUROSCIENCES 103559-D11

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR