BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1X U

    MDR report key: 1067531 · Received June 25, 2008

    Report

    Report Number
    2023988-2008-00022
    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 INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE PROBE WAS INSERTED TO A DEPTH OF 15MM IN A PATIENT WHO HAD HAD A SUBARACHNOID HEMORRHAGE FROM A POSTERIOR INFERIOR CEREBELLAR ARTERY ANEURYSM. FOR ABOUT TWO TO THREE MINUTES AFTER INSERTION CEREBRAL BLOOD FLOW (CBF) AND INTRACRANIAL PRESSURE READINGS THAT WERE CONSISTENT WITH ALTERNATIVE CONCURRENT MONITORING WERE OBTAINED. WHILE CALIBRATING THE DEVICE TO THE BEDSIDE MONITOR THE CBF READINGS WERE LOST AND COULD NOT BE REGAINED. THE PHYSICIAN ATTEMPTED TO REPOSITION THE PROBE, BUT AS NO READING COULD BE OBTAINED THE PROBE AND THE BOLT WERE DISCONTINUED. THE PT LATER HAD SUCCESSFUL ANEURYSM SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1X U NONE GWM INTEGRA NEUROSCIENCES NS-P 103559-E17

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR