BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN-V

    MDR report key: 2864522 · Received December 6, 2012

    Report

    Report Number
    2021898-2012-00407
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN AS IT REMAINS IMPLANTED IN THE PATIENT. THEREFORE, AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING 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

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT HAS EXPERIENCED EPISODES OF NAUSEA, DISORIENTATION, DUSKY APPEARANCE, FEVER, HEADACHE AND NON-RESPONSIVENESS. AT THE TIME THE REPORT WAS MADE, IT WAS STATED THAT THE FOUR-YEAR-OLD PATIENT WITH DIAGNOSED HYDROCEPHALUS HAD ALREADY UNDERGONE THREE REVISIONS AND THAT A MEDICAL EXAMINATION RULED OUT SEIZURES. REPORTEDLY, THE PATIENT'S MOTHER BELIEVES THAT A POTENTIAL SHUNT MALFUNCTION IS RESPONSIBLE FOR THESE SYMPTOMS. HOWEVER, THE REPORT ALSO STATES THAT THE NEUROSURGEON HANDLING THE PATIENT'S TREATMENT BELIEVES THE SYMPTOMS ARE ATTRIBUTABLE TO A SENSITIVITY TO PRESSURE CHANGE, AND ARE INDUCED BY THE SLIGHTEST DILATION OF THE VENTRICLES. ACCORDING TO THE REPORT, THUS FAR THE PHYSICIAN HAS NOT DEEMED THAT SURGICAL INTERVENTION OR REVISION OF THE SHUNT IS WARRANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR