BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1XL

    MDR report key: 671250 · Received September 9, 2005

    Report

    Report Number
    2023988-2005-00037
    Event Type
    Malfunction
    Date Received
    September 9, 2005
    Report Date
    September 9, 2005
    Manufacturer
    INTEGRA NEURO SCIENCES
    Product Code
    DPW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A CBF (CEREBRAL BLOOD FLOW) MONITOR AND EVD WERE PLACED. THE SURGEON DID NOT UTILIZED A LICOX. THE CBF AND ICP WAVEFORM NEVER MATERIALIZED AT EITHER 20MM OR 25MM DEPTHS. THE NEUROSURGEON FELT IT MAY HAVE BEEN ATTRIBUTED TO THE PT'S SKULL PATHOLOGY. THE PT'S HEAD CT WAS VIEWED AND THE SKULL APPEARED VERY THICK, IT WAS ALSO OBSERVED THAT THE NEUROSURGEON PLACED THE CATHETERS MORE ANTERIOR THAN WHAT THE DIRECTIONS FOR USE (DFU) RECOMMENDS. GIVEN THE THICK BONE AND UNK DEPTH OF THE SUBARACHNOID SPACE, THE CATHETER MAY BE LOCATED IN THE PARENCHYMA. LOW CBF AND ICP VALUES WERE OBSERVED, HOWEVER, THE WAVEFORM WAS A FLAT LINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1