BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MEDIUM PRESSURE VALVE

    MDR report key: 2728950 · Received August 31, 2012

    Report

    Report Number
    2021898-2012-00283
    Event Type
    Injury
    Date Received
    August 31, 2012
    Date of Event
    August 1, 2012
    Report Date
    August 3, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC NEUROSURGERY HAS NOT RECEIVED REPLIES TO REQUESTS FOR INFORMATION REGARDING THE NUMBER OF PTS EXPERIENCING COLLAPSED VENTRICLES, THE EVENT DATES OF SUCH OCCURRENCES, AND ANY ALLEGED MALFUNCTION OF MEDTRONIC NEUROSURGERY DEVICES. IT IS UNKNOWN IF FACTORS IN HYDROCEPHALUS TREATMENT MAY HAVE CAUSED OR CONTRIBUTED TO THE COLLAPSED VENTRICLES. THE PRODUCT(S) WERE UNAVAILABLE FOR RETURN. THEREFORE DEVICE EVALUATION(S) WERE NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS LOT NUMBER(S) WERE NOT POSSIBLE AS LOT NUMBER(S) WERE NOT PROVIDED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PHYSICIAN HAS HAD PTS IMPLANTED WITH MEDIUM PRESSURE VALVES THAT HAVE EXPERIENCED COLLAPSING VENTRICLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN MEDIUM PRESSURE VALVE JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other