BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA VALVE REG, LEVEL 1.5

    MDR report key: 1924737 · Received December 9, 2010

    Report

    Report Number
    2021898-2010-00346
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    October 8, 2010
    Report Date
    November 10, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K902783
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED DEVICE WAS PATENT, PASSED SIPHON AND REFLUX TESTING AND WAS IN SPECIFICATIONS FOR PRESSURE-FLOW TESTING AT -50 CM HYDROSTATIC PRESSURE. HOWEVER, THE VALVE DID NOT MEET SPECIFICATIONS FOR PRESSURE-FLOW AND PREIMPLANTATION TESTING AT 0 CM HYDROSTATIC PRESSURE. CRYSTALLINE DEBRIS FOUND WITHIN THE VALVE MECHANISM MAY HAVE AFFECTED FLOW RATES. THE VALVE DID NOT MEET REQUIREMENTS FOR LEAK TESTING DUE TO PINHOLES IN THE SILICONE DOME ABOUT THE RESERVOIR AND IN THE TOP OF THE DELTA CHAMBER. IT IS UNK 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 MFG RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. NO PT IMPACT WAS REPORTED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DELTA VALVE WAS EXPLANTED ON (B)(6) 2010 AND SURGEON WANTED TO KNOW IF IT STILL FUNCTIONS PROPERLY. IT WAS IMPLANTED SEVERAL YRS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA VALVE REG, LEVEL 1.5 JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization