BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN STRATA VALVE/SHUNT

    MDR report key: 4874180 · Received June 25, 2015

    Report

    Report Number
    2021898-2015-00229
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Report Date
    May 26, 2015
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS IDENTIFIED ON AN ONLINE MEDICAL FORUM AND THERE WAS NO CONTACT INFORMATION AVAILABLE FOR THE INITIAL REPORTER. THEREFORE, IT WAS NOT POSSIBLE TO OBTAIN ANY FURTHER INFORMATION REGARDING THE EVENT. THIS EVENT COULD NOT BE MATCHED TO A PREVIOUSLY REPORTED EVENT TO MEDTRONIC NEUROSURGERY. THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE, AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. IT IS UNKNOWN IF THE PATIENT'S VALVE SITE HAD BEEN EXPOSED TO STRONG MAGNETS. STRATA PRODUCTS ARE DESIGNED TO BE ADJUSTED BY A STRONG MAGNET. INADVERTENT ADJUSTMENTS BY EXTERNAL MAGNETS ARE A KNOWN COMPLICATION WITH ADJUSTABLE VALVES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT HAD AN INADVERTENT LEVEL CHANGE WITH THEIR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411709 UNKNOWN STRATA VALVE/SHUNT SHUNT,CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1