BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA 2 VALVE, REGULAR

    MDR report key: 2030902 · Received March 21, 2011

    Report

    Report Number
    2021898-2011-00061
    Event Type
    Injury
    Date Received
    March 21, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 20, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIRST VALVE WAS EXPLANTED, BUT IS 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. STRATA PRODUCTS ARE DESIGNED TO BE ADJUSTED BY A STRONG MAGNET. INADVERTENT ADJUSTMENTS BY EXTERNAL MAGNETS ARE A KNOWN COMPLICATION WITH ADJUSTABLE VALVES. WHILE IT IS IMPOSSIBLE TO QUANTIFY ALL THE VARIOUS MAGNETIC FIELDS IN OUR ENVIRONMENT, THE VAST MAJORITY WILL NOT IMPACT THE VALVE AS LONG AS DISTANCE FROM THE VALVE IMPLANT IS MAINTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A PATIENT HAS INTRACRANIAL HYPERTENSION AND HAD A STRATA II SHUNT IMPLANTED. THE STRATA II SHUNT WAS REPLACED BECAUSE IT ALLEGEDLY FREQUENTLY RESET ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA 2 VALVE, REGULAR JXP JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R