BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1XL

    MDR report key: 671119 · Received September 9, 2005

    Report

    Report Number
    2023988-2005-00039
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE NEUROSURGEON, HE INSERTED A NEUROSENSOR PROBE AND GOT READINGS OF 0-2CC/100GM/MIN. THE PT HAD A NORMAL PBTO2 BUT NO CBF. ICP WORKED WELL AND CORRELATED WITH THE CAMINO VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1XL NEUROSENSOR DPW INTEGRA NEURO SCIENCES * W050980

    Patients

    Seq Age Sex Outcome Treatment
    1 *