BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA SHUNT KIT REGULAR, PL 1.5

    MDR report key: 1841800 · Received September 21, 2010

    Report

    Report Number
    2021898-2010-00226
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    July 13, 2010
    Report Date
    August 25, 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 DEVICE WAS PATENT, PASSED SIPHON AND REFLUX TESTING AND WAS WITHIN SPECIFICATIONS FOR PRESSURE-FLOW AND PREIMPLANTATION TESTING. HOWEVER, IT DID NOT MEET THE REQUIREMENTS FOR LEAK TESTING DUE TO A TEAR IN THE TOP OF THE DELTA CHAMBER. IT IS UNK HOW OR WHEN THIS DAMAGE OCCURRED. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE PRODUCT CAUTION THAT CARE SHOULD BE TAKEN IN HANDLING THE PRODUCT 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 IMPLANT, THE SURGEON FOUND THAT THE CHAMBER WAS LEAKING, SO HE CHANGED ANOTHER PRODUCT AND FINISHED THE OPERATION SAFELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA SHUNT KIT REGULAR, PL 1.5 JXG MEDTRONIC NEUROSURGERY NA C60737

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK