BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA II

    MDR report key: 4780531 · Received May 12, 2015

    Report

    Report Number
    4780531
    Event Type
    Malfunction
    Date Received
    May 12, 2015
    Date of Event
    April 22, 2015
    Report Date
    May 12, 2015
    Manufacturer
    MEDTRONIC
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE OPERATIVE REPORT THERE "WAS A CRACK IN THE PLASTIC AT THE AREA OF THE DELTA RESERVOIR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310440 STRATA II SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR