BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA VALVE, REGULAR, BIOGLIDE, PL 2.0

    MDR report key: 3093697 · Received May 1, 2013

    Report

    Report Number
    2021898-2013-00164
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K951258
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS PATENT. PROTEINACEOUS DEBRIS WAS OBSERVED IN ITS INTERIOR. THE VALVE MET REQUIREMENTS FOR THE SIPHON AND REFLUX TESTS. IT DID NOT MEET REQUIREMENTS FOR THE LEAKAGE AND PREIMPLANTATION TESTS. IT ALSO DID NOT MEET ALL OF THE REQUIREMENTS FOR THE PRESSURE-FLOW TESTS. MULTIPLE TEARS WERE OBSERVED ON BOTH SIDES OF THE PROXIMAL OCCLUDER. IT IS UNKNOWN HOW OR WHEN THIS DAMAGE OCCURRED. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT CARE SHOULD BE TAKEN IN HANDLING THE VALVES AS SILICONE AS A LOW CUT AND TEAR RESISTANCE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A VP SHUNT WAS EXPLANTED FROM A PATIENT BECAUSE IT HAD FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189622 DELTA VALVE, REGULAR, BIOGLIDE, PL 2.0 JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| R