BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 972285 · Received December 19, 2007

    Report

    Report Number
    2023988-2007-00077
    Event Type
    Malfunction
    Date Received
    December 19, 2007
    Report Date
    December 19, 2007
    Manufacturer
    INTEGRA NEUROSCIENCES
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT INTRA-CRANIAL PRESSURE (ICP) FIBEROPTIC READINGS WERE NEGATIVE WHEN THE HEAD OF BED (HOB) WAS AT 30 DEGREES. WHEN THE HOB WAS FLAT, THE READINGS RANGED FROM 9 TO 11 WITH A GOOD WAVEFORM. NO REVISION WAS REQUIRED, AND THE CATHETER REMAINED INSERTED FOR 2 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRACRANIAL PRESSURE MONITORING KIT NONE GWM INTEGRA NEUROSCIENCES W051780

    Patients

    Seq Age Sex Outcome Treatment
    1 YR