BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLARIS ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 655108 · Received December 13, 2005

    Report

    Report Number
    3001587388-2005-00037
    Event Type
    Other
    Date Received
    December 13, 2005
    Date of Event
    October 29, 2005
    Report Date
    December 12, 2005
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS POLARIS ADJUSTABLE PRESSURE VALVE SPV WAS IMPLANTED TO A PATIENT IN 2005 24 HOURS AFTER IMPLANTATION, THE VALVE SEEMED TO BE NOT FUNCTIONAL. THE NEUROSURGEON THOUGHT THAT THE RESISTANCE BEGAN PROBABLY TOO HIGH AND THE PRESSURE OF OPENING DID NOT MORE CORRESPOND TO THE DISPLAYED PRESSURE. SO, THE NEUROSURGEON REVISED THE VALVE.

    Description of Event or Problem · 1

    THIS POLARIS ADJUSTABLE PRESSURE VALVE SPV WAS IMPLANTED TO A PT IN 2005. 24 HOURS AFTER IMPLANTATION, THE VALVE SEEMED TO BE NOT FUNCTIONAL. THE NEUROSURGEON THOUGHT THAT THE RESISTANCE BEGAN PROBABLY TOO HIGH AND THE PRESSURE OF OPENING DID NOT MORE CORRESPOND TO THE DISPLAYED PRESSURE. SO, THE NEUROSURGEON REVISED THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS ADJUSTABLE PRESSURE VALVE SHUNT SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG SOPHYSA POLARIS VALVE R0257

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other