BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1X U

    MDR report key: 1338476 · Received December 18, 2008

    Report

    Report Number
    2023988-2008-00048
    Event Type
    Malfunction
    Date Received
    December 18, 2008
    Date of Event
    November 17, 2008
    Report Date
    December 18, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE NEUROSENSOR CATHETER WAS USED TO MONITOR A PT WHO HAD SUFFERED A SUBARACHNOID HEMORRHAGE. THE RPTR STATED THAT THE PT WAS SENT FOR A CT SCAN. WHEN THE PT RETURNED FROM THE INVESTIGATION, THE PROBE WAS BENT AND NOT READING CORRECTLY. THE PROBE WAS REMOVED, BUT NOT SAVED FOR INVESTIGATION. THE PT DIED LATER THAT DAY, HOWEVER, THIS OUTCOME WAS NOT RELATED TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1X U NEUROSENSOR CBF/ICP CATHETER GWM INTEGRA NEUROSCIENCES 305000125273

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR