BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1X

    MDR report key: 972287 · Received December 19, 2007

    Report

    Report Number
    2023988-2007-00076
    Event Type
    Malfunction
    Date Received
    December 19, 2007
    Report Date
    December 19, 2007
    Manufacturer
    INTEGRA NEUROSCIENCES
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE INTRA-CRANIAL PRESSURE (ICP) READINGS WERE NOT ACCURATE. THE ICP READINGS WERE NEGATIVE; THE CEREBRAL BLOOD FLOW (CBF) READINGS STAYED CONSTANT IN THE MID-TEENS THROUGHOUT THE WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1X NONE GWM INTEGRA NEUROSCIENCES NS-P 305000102304

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR