BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA VALVE, REGULAR, WITH BIOGLIDE, PERFORMANCE LEVEL 2

    MDR report key: 3941960 · Received July 17, 2014

    Report

    Report Number
    2021898-2014-00250
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K951258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. (B)(4).

    Additional Manufacturer Narrative · 1

    PROTEINACEOUS DEBRIS WAS OBSERVED IN THE INTERIOR OF THE RETURNED VALVE. THE VALVE WAS PATENT. HOWEVER, IT DID NOT MEET ALL OF THE REQUIREMENTS FOR SIPHON, REFLUX, PREIMPLANTATION, PRESSURE-FLOW, AND LEAKAGE TESTS. TWO TEARS WERE OBSERVED ON THE RESERVOIR DOME. ADDITIONALLY A TEAR WAS OBSERVED ON THE TOP DELTA CHAMBER MEMBRANE. IT IS UNKNOWN HOW OR WHEN THE DAMAGE OCCURRED. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE STATE THAT IMPROPER USE OF INSTRUMENTS IN THE HANDLING OR IMPLANTATION OF SHUNT PRODUCTS MAY RESULT IN THE CUTTING, SLITTING OR CRUSHING OF COMPONENTS. A REVIEW OF MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT AFTER OPENING THE VALVE, IT WAS FOUND NOT TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418283 DELTA VALVE, REGULAR, WITH BIOGLIDE, PERFORMANCE LEVEL 2 SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D40008

    Patients

    Seq Age Sex Outcome Treatment
    1