BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA VALVE, SMALL, PL 1.0

    MDR report key: 2971606 · Received January 30, 2013

    Report

    Report Number
    2021898-2013-00027
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Report Date
    October 24, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K902783
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS PATENT. HOWEVER, THE DEVICE DID NOT MEET SPECIFICATIONS FOR LEAK, SIPHON, REFLUX, PRESSURE-FLOW, AND PREIMPLANTATION TESTING DUE TO BOTH THE ABUNDANCE OF DEBRIS WITHIN THE VALVE AND A SMALL TEAR AT THE TOP ANTERIOR PORTION OF THE RESERVOIR. IT IS UNK HOW OR WHEN THIS DAMAGE OCCURRED. DEBRIS WITHIN THE VALVE MAY HOLD PRESSURE-FLOW CONTROLLING MECHANISMS OPEN, RESULTING IN FLUID REFLUX AND OR/SIPHONING. ALSO, 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 SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO MEDTRONIC NEUROSURGERY WITHOUT CONTAINING ANY INFO RELATED TO AN ALLEGED COMPLAINT OR THE IDENTIFY OF THE SOURCE FROM WHICH IT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41886 DELTA VALVE, SMALL, PL 1.0 JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY C32288

    Patients

    Seq Age Sex Outcome Treatment
    1