BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1

    MDR report key: 2151232 · Received June 21, 2011

    Report

    Report Number
    2021898-2011-00137
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 24, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K902783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS PATENT AND PASSED SIPHON TESTING. THE DEVICE DID NOT MEET THE REQUIREMENTS FOR REFLUX OR LEAK TESTING DUE TO MULTIPLE TEARS IN THE TOP OF THE DELTA CHAMBER. IT IS UNKNOWN HOW OR WHEN THIS DAMAGE OCCURRED. THE DEVICE MET ALL SPECIFICATIONS FOR PRESSURE-FLOW AND PREIMPLANTATION 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. NO IMPACT TO PATIENT REPORTED. 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 DURING PREIMPLANTATION TESTING, THE DOCTOR FOUND THE SHUNT LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1 JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY C72147

    Patients

    Seq Age Sex Outcome Treatment
    1