BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1X U

    MDR report key: 1067532 · Received June 25, 2008

    Report

    Report Number
    2023988-2008-00021
    Event Type
    Malfunction
    Date Received
    June 25, 2008
    Date of Event
    May 31, 2008
    Report Date
    June 25, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE NEUROSENSOR PROBE SHOULD BE CALIBRATED TO ZERO PRIOR TO USE. THE USER DID NOT PRE- CALIBRATE THE DEVICE TO ZERO BEFORE IT WAS INSERTED. THE PATIENT HAD A SUBARACHNOID HEMORRHAGE FROM A RUPTURED POSTERIOR INFERIOR CEREBELLAR ARTERY ANEURYSM. THE NEUROSENSOR PROBE WAS INSERTED TO A DEPTH OF 5MM. THE ACCURACY OF THE READINGS, WHEN COMPARED TO ALTERNATIVE MONITORING, WERE DOUBTED DUE TO FAILURE TO ZERO THE DEVICE. ANOTHER PROBE NEEDED TO BE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1X U NEUROLOGICAL DIAGNOSTIC DEVICE GWM INTEGRA NEUROSCIENCES 103559-E16

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR