BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5

    MDR report key: 2982880 · Received February 25, 2013

    Report

    Report Number
    2021898-2013-00065
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 29, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K902783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE DID NOT MEET THE SPECIFICATIONS FOR PATENCY OR LEAK TESTING DUE TO A TEAR IN THE TOP MEMBRANE OF THE DELTA CHAMBER. IT IS UNK HOW OR WHEN THIS DAMAGE OCCURRED. THE DAMAGE PRECLUDED SIPHON, REFLUX, PRESSURE-FLOW AND PRE-IMPLANTATION TESTING. 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 MANUFACTURING 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 TO MEDTRONIC NEUROSURGERY THAT THE VALVE WAS FOUND TO BE LEAKING DURING PRE-IMPLANTATION TESTING. NO IMPACT TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78983 DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5 JXG - SHUNT, CENTRAL NERVOUS SYTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D12568

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR