BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLARIS ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 5345165 · Received December 30, 2005

    Report

    Report Number
    3001587388-2005-00384
    Event Type
    Other
    Date Received
    December 30, 2005
    Date of Event
    December 9, 2005
    Report Date
    December 30, 2005
    Manufacturer
    SOPHYSA
    Product Code
    GYK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE HAS BEEN RETURNED IN (B)(4) 2005. ANALYSIS HAS TO BE DONE. SEE SANNED PAGE.

    Description of Event or Problem · 1

    THIS POLARIS ADJUSTABLE PRESSURE VALVE WAS IMPLANTED TO A PT IN (B)(6). THE IMPLANTATION DEPTH WAS LESS THAN 10 MM FROM THE SKIN. IN EARLY (B)(6), THE NEUROSURGEON ATTEMPTED TO DECREASE THE SETTING PRESSURE OF THE VALVE TO 330 MMH2O ( OR 230 MMH2O) WITH AN ADJUSTMENT MAGNET AND A PRESSURE SELECTOR, IN VAIN. HE REPLACED THE VALVE WITH ANOTHER SPV-400 IN (B)(6). HE SUCCEEDED IN CHANGING THE PRESSURE OF THE EXPLANTED VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS ADJUSTABLE PRESSURE VALVE SHUNT SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS GYK SOPHYSA POLARIS (R) VALVE P0322

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other