BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5

    MDR report key: 2142053 · Received May 16, 2011

    Report

    Report Number
    2021898-2011-00102
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    February 26, 2011
    Report Date
    April 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. HOWEVER, IT DID NOT MEET THE REQUIREMENTS FOR LEAK AND REFLUX TESTING DUE TO A TEAR IN THE TOP OF THE DELTA CHAMBER. IT IS UNK HOW OR WHEN THIS DAMAGE OCCURRED. THE DAMAGE PRECLUDED 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 MFG RECORDS SHOWED NO ANOMALIES. NO IMPACT TO THE PT WAS 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 IMPLANTATION, THE DOCTOR ALLEGEDLY FOUND THE VALVE LEAKING. THE DOCTOR REPLACED THE VALVE WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5 JXG MEDTRONIC NEUROSURGERY C71378

    Patients

    Seq Age Sex Outcome Treatment
    1