BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1X

    MDR report key: 1162163 · Received September 15, 2008

    Report

    Report Number
    2023988-2008-00010
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    February 21, 2008
    Report Date
    September 15, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RETURNED FOR EVALUATION. ONE PROBE WAS TOO DAMAGED (OWING TO EXTREME DAMAGE BY CUSTOMER) TO FACILITATE TESTING OR VERIFY COMPLAINT. THE SECOND UNIT WAS TESTED; THE FAILURE MODE REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. DEVICE HISTORY RESEARCH (DHR) FAILED TO REVEAL ANY ANOMALIES DURING MANUFACTURE OR INSPECTION. BASED ON THE REPORTED INFORMATION, AND THE INVESTIGATION RESULTS PROVIDED, INTEGRA CONSIDERS THIS COMPLAINT CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE REPORTER STATES THAT UPON PLACEMENT OF THE PROBE IN THE OPERATING ROOM, THE CEREBRAL BLOOD FLOW (CBF) VALUE DID NOT READ AS THE SURGEON EXPECTED. THE SURGEON OBSERVED THAT THE CBF READING WAS LOW. THE CBF READING CONTINUED TO FLUCTUATE THROUGHOUT THE NEXT 72 HOURS WHILE THE PRODUCT REMAINED IN THE PATIENT. THE INTERCRANIAL PRESSURE (ICP) VALUE WAS OBSERVED TO DROP FROM NORMAL INITIAL RANGE TO A NEGATIVE -5MMHG VALUE AFTER THE MONITOR WAS TURNED OFF, AND BROUGHT FROM THE OR INTO THE POST ANESTHETIC CARE UNIT. (45 MINUTES ELAPSING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1X NEURO SENSOR PROBE GWM INTEGRA NEUROSCIENCES NS-P

    Patients

    Seq Age Sex Outcome Treatment
    1