BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA VALVE REG, LEVEL 1.5

    MDR report key: 1882676 · Received October 13, 2010

    Report

    Report Number
    2021898-2010-00251
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 15, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K902783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS PATENT, PASSED SIPHON AND REFLUX TESTING AND MET SPECIFICATIONS FOR PRESSURE-FLOW TESTING AT 50 CM HYDROSTATIC PRESSURE. HOWEVER, IT DID NOT MEET THE REQUIREMENTS FOR LEAK TESTING AND WAS NOT WITHIN SPECIFICATIONS FOR PRESSURE FLOW AND PREIMPLANTATION TESTING AT 0 CM HYDROSTATIC PRESSURE. THERE WAS A SMALL TEAR IN THE TOP OF THE DELTA CHAMBER. IT IS UNKNOWN HOW OR WHEN THIS DAMAGE OCCURRED. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE PRODUCT CAUTION THAT CARE SHOULD BE TAKEN IN HANDLING THE PRODUCT 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

    THE DEVICE WAS REPORTED DEFECTIVE UPON IMPLANTATION AND WAS NOT USEABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA VALVE REG, LEVEL 1.5 JXG MEDTRONIC NEUROSURGERY NA C39363

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK