BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATA SHUNT

    MDR report key: 1910688 · Received November 22, 2010

    Report

    Report Number
    2021898-2010-00315
    Event Type
    Injury
    Date Received
    November 22, 2010
    Report Date
    July 1, 2009
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT REMAINS IMPLANTED AND 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

    THE PT REPORTED THAT SHE HAD A STRATA II SHUNT IMPLANTED ON (B)(6), 2009, AND HAD SERIOUS EFFECTS AND PAIN. THE SHUNT WAS FOUND NOT TO BE WORKING PROPERLY AND WAS REVISED ON (B)(6), 2009. THE SHUNT WAS EMBEDDED INCORRECTLY IN THE PATIENT'S ABDOMEN, WHICH CAUSED INFLAMMATION. ANOTHER SURGERY WAS PERFORMED ON (B)(6). THE PATIENT REPORTED PROBLEMS WITH BALANCE AND SOME MOTOR SKILL DIFFICULTY.

    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