BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA II VALVE, REGULAR

    MDR report key: 2971111 · Received February 1, 2013

    Report

    Report Number
    2021898-2013-00028
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    December 23, 2012
    Report Date
    January 4, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS PATENT. IT MET REQUIREMENTS FOR THE REFLUX AND PREIMPLANTATION TESTS. IT ALSO MET ALL OF THE REQUIREMENTS FOR THE PRESSURE-FLOW TESTS. THE VALVE DID NOT MEET REQUIREMENTS FOR THE SIPHON AND LEAKAGE TEST. FOUR TEARS WERE OBSERVED ON THE DELTA CHAMBER MEMBRANES. IT IS UNKNOWN HOW OR WHEN THIS DAMAGE OCCURRED. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT CARE SHOULD BE TAKEN IN HANDLING THE VALVES AS SILICONE HAS A LOW CUT AND TEAR RESISTANCE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE SURGEON FOUND THE DELTA CHAMBER TO BE LEAKING WHEN HE PERFORMED THE PRE-OPERATIVE VALVE TESTS. IT WAS ALSO REPORTED THAT THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45294 STRATA II VALVE, REGULAR JXG - SHUNT, CENTERAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY C82853

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR