BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA II, ADJUSTABLE DELTA VALVE, SMALL

    MDR report key: 1701280 · Received May 14, 2010

    Report

    Report Number
    2021898-2010-00092
    Event Type
    Malfunction
    Date Received
    May 14, 2010
    Date of Event
    April 20, 2010
    Report Date
    April 21, 2010
    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

    (B) (4). THE VALVE DID NOT MEET THE REQUIREMENTS FOR LEAK TESTING DUE TO A TEAR ON THE RESERVOIR DOME. THIS PRECLUDED SIPHON AND REFLUX TESTING AS WELL AS MEASUREMENT OF PRESSURE FLOW CHARACTERISTICS AND PREIMPLANTATION TESTING. IT IS UNKNOWN HOW OR WHEN THE DAMAGE OCCURRED. THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THE DEVICE CAUTIONS 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 OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREOPERATIVE TESTING, THE CHAMBER WAS FOUND BROKEN WITH LEAKAGE. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA II, ADJUSTABLE DELTA VALVE, SMALL 84JXG JXG MEDTRONIC NEUROSURGERY NA C46000

    Patients

    Seq Age Sex Outcome Treatment
    1