BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA 2, ADJUSTABLE VALVE, REGULAR

    MDR report key: 2020591 · Received February 10, 2011

    Report

    Report Number
    2021898-2011-00028
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Report Date
    January 11, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE NATURE OF THIS COMPLAINT COULD NOT BE ESTABLISHED AND F/U WAS NOT POSSIBLE. THE VALVE WAS PATENT, PASSED SIPHON TESTING AND MET ALL ESTABLISHED SPECIFICATIONS FOR PRESSURE-FLOW AND PREIMPLANTATION TESTING. THE DEVICE DID NOT MEET THE REQUIREMENTS FOR LEAK TESTING DUE TO A SMALL TEAR IN THE TOP OF THE DELTA CHAMBER. THIS PRECLUDED REFLUX TESTING. IT IS UNK 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. NO IMPACT TO PT REPORTED. ALL OUR VALVES ARE 100% TESTED AT TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE VALVE WAS RETURNED IN ORDER TO BE EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA 2, ADJUSTABLE VALVE, REGULAR JXG MEDTRONIC NEUROSURGERY NA C71911

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK