BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA SHUNT KIT REGULAR, PL 1.5

    MDR report key: 1676437 · Received April 29, 2010

    Report

    Report Number
    2021898-2010-00082
    Event Type
    Malfunction
    Date Received
    April 29, 2010
    Date of Event
    March 29, 2010
    Report Date
    March 31, 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 IT DID NOT PASS LEAK TESTING DUE TO A TEAR ON THE TOP 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 ACCOMPANIES THE DEVICE CAUTIONS THAT CARE SHOULD BE TAKEN IN HANDLING THE VALVES AS SILICONE HAS A LOW CUT AND TEAR RESISTANCE. IT IS ALSO SUGGESTED THAT THE VALVE BE PLACED IN A SURGICALLY CREATED LOOSE SUBGALEAL POCKET. THIS ALLOWS GENTLE PLACEMENT OF THE VALVE AND MINIMIZES HANDLING WITH SURGICAL TOOLS. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE OPERATION OF IMPLANTATION, THE SURGEON DISCOVERED THAT THE VALVE WAS LEAKING FOR UNK REASON. SO HE CHANGED TO ANOTHER NEW 25132-5 AND SENT THE LEAKING PRODUCT BACK FOR REPLACEMENT. THERE WAS NO IMPACT TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1