BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA SHUNT KIT REGULAR, PL 1.5

    MDR report key: 1661637 · Received April 15, 2010

    Report

    Report Number
    2021898-2010-00062
    Event Type
    Malfunction
    Date Received
    April 15, 2010
    Date of Event
    June 30, 2009
    Report Date
    March 23, 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. THIS 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. 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 MFG RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTATION, THERE WAS A LEAK NOTICED IN THE DELTA CHAMBER. THE VALVE WAS REPLACED AND 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 C38053

    Patients

    Seq Age Sex Outcome Treatment
    1