BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1XL

    MDR report key: 664302 · Received September 15, 2005

    Report

    Report Number
    2023988-2005-00044
    Event Type
    Malfunction
    Date Received
    September 15, 2005
    Report Date
    September 15, 2005
    Manufacturer
    INTEGRA NEUROSCIENCES
    Product Code
    DPW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THREE INCIDENTS WERE REPORTED BY THIS USER FACILITY. WHILE ZEROING THE ICP PORTION OF THE PROBE, A SIGNIFICANT DIFFERENCE BETWEEN THE PROBE READINGS IN THE VIAL AND THE PROBE READINGS OUTSIDE THE VIAL WERE OBSERVED. ALSO MENTIONED WERE BIG DIFFERENCES BETWEEN CBF MEASUREMENTS FROM THE GREY TO WHITE MATTER. THE PHYSICIAN EXPRESSED A GREATER CONCERN WITH THE DIFFERENCE IN THE ICP MEASUREMENTS THAN WITH THE CBF MEASUREMENTS. THIS MEDICAL REPORT IS LINKED TO MEDICAL DEVICE REPORT 2023988-2005-00042 AND #2023988-2005-00045.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1XL NEUROSENSOR DPW INTEGRA NEUROSCIENCES * W050708

    Patients

    Seq Age Sex Outcome Treatment
    1 *