BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA 2, ADJUSTABLE VALVE, REGULAR

    MDR report key: 1950227 · Received December 9, 2010

    Report

    Report Number
    2021898-2010-00344
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 10, 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 WAS PATENT, BUT DID NOT MET THE REQUIREMENTS FOR LEAK TESTING DUE TO LARGE TEARS IN THE TOP THE DELTA CHAMBER. THIS PRECLUDED SIPHON AND REFLUX TESTING AS WELL AS MEASUREMENT OF PRESSURE FLOW CHARACTERISTIC AND PREIMPLANTATION TESTING. IT IS UNK 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. IT IS ALSO SUGGESTED THAT THE VALVE BE PLACED IN A SURGICALLY CREATED LOOSE SUBGALEAL POCKET. THIS ALLOWS GENTLE PLACEMENT OF THE VALVE AND MINIMIZES HANDLING WITH SURGICAL TOOLS. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. NO PT IMPACT WAS REPORTED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DELTA CHAMBER OF THE VALVE WAS BROKEN DURING IMPLANTATION.

    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