BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA 2, ADJUSTABLE VALVE, REGULAR

    MDR report key: 2013531 · Received February 3, 2011

    Report

    Report Number
    2021898-2011-00026
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    December 30, 2010
    Report Date
    January 5, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE VALVE WAS PATENT, BUT DID NOT MEET THE REQUIREMENTS FOR LEAK TESTING DUE TO LARGE TEARS IN THE BOTTOM AND SIDE OF THE DELTA CHAMBER. THIS PRECLUDED SIPHON AND REFLUX TESTING AS WELL AS MEASUREMENT OF PRESSURE-FLOW CHARACTERISTICS AND PREIMPLANTATION TESTING. IT IS UNKNOWN HOW OR WHEN THESE DAMAGES 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. NO IMPACT TO PATIENT REPORTED. ALL OF OUR VALVES ARE 100% TESTED AT TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING PREIMPLANTATION TESTING, THE SIDE OF THE DELTA CHAMBER WAS FOUND LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA 2, ADJUSTABLE VALVE, REGULAR JXG MEDTRONIC NEUROSURGERY NA C66638

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK