BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA VALVE, REGULAR, LEVEL 2.0

    MDR report key: 1854261 · Received September 3, 2010

    Report

    Report Number
    2021898-2010-00205
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    July 29, 2010
    Report Date
    August 9, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K902783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE VALVE WAS PATENT, AND PASSED SIPHON AND PRESSURE FLOW TESTING AT 20.4 ML/HR (-50CM HP). HOWEVER, THE VALVE DID NOT PASS LEAK TESTING DUE TO A SMALL TEAR ON THE TOP OF THE DELTA CHAMBER. 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. 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. THE VALVE PERFORMANCE DID NOT MEET ALL OTHER ESTABLISHED SPECS FOR REFLUX, PRESSURE-FLOW, AND PRE-IMPLANTATION TESTING. DEBRIS WITHIN THE VALVE MAY INTERFERE WITH THE MEMBRANE RESULTING IN LOW PRESSURE-FLOW RESULTS AND REFLUX. A REVIEW OF MFG RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAK IN THE VALVE. THERE WAS A VERY TINY HOLE, LIKE A PINHOLE. THE PT IMPACT WAS MINIMAL, AS THEY NOTICED THE LEAK AND IMPLANTED A NEW PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA VALVE, REGULAR, LEVEL 2.0 JXG MEDTRONIC NEUROSURGERY NA C29385

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK