BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATA SHUNT

    MDR report key: 1910677 · Received November 22, 2010

    Report

    Report Number
    2021898-2010-00314
    Event Type
    Injury
    Date Received
    November 22, 2010
    Report Date
    June 29, 2009
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS UNAVAILABLE FOR RETURN. THEREFORE, AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MFG 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

    A PATIENT FAMILY MEMBER REPORTED THAT HER SON HAS A STRATA SHUNT SYSTEM WITH ONE REVISION TO DATE. SWELLING WAS NOTED AROUND THE SHUNT WITH INCREASED ICP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN STRATA SHUNT JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R