BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA SHUNT KIT REGULAR, PL 1.5

    MDR report key: 1724267 · Received June 4, 2010

    Report

    Report Number
    2021898-2010-00104
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Date of Event
    April 26, 2010
    Report Date
    May 6, 2010
    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

    (B) (4). THE VALVE WAS PATENT, BUT DID NOT PASS LEAK TESTING DUE TO A LARGE HOLE IN THE SIDE OF THE DELTA CHAMBER. THE PRECLUDED SIPHON AND REFLUX TESTING AS WELL AS MEASUREMENT OF PRESSURE FLOW CHARACTERISTICS 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. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MFR.

    Description of Event or Problem · 1

    DURING THE OPERATION, WHEN THE DOCTOR DID THE PATENCY TEST, A LEAK IN THE VALVE WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA SHUNT KIT REGULAR, PL 1.5 JXG MEDTRONIC NEUROSURGERY NA C46951

    Patients

    Seq Age Sex Outcome Treatment
    1