BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1X

    MDR report key: 737483 · Received July 8, 2005

    Report

    Report Number
    2023988-2005-00026
    Event Type
    Malfunction
    Date Received
    July 8, 2005
    Report Date
    July 8, 2005
    Manufacturer
    INTEGRA NEURO SCIENCES
    Product Code
    DPW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    WHILE IN USE, THE NEUROSENSOR PROBE HAD A SUDDEN RISE IN VALUES (CBF AND ICP). WHEN THE CBF NORMALIZED, THE ICP READ ZERO AND REMAINED AT ZERO FOR THE REMAINDER OF SURGERY. THERE WAS NO PT INJURY INVOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *