BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA 2 VALVE, SMALL

    MDR report key: 3914511 · Received July 3, 2014

    Report

    Report Number
    2021898-2014-00227
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K012052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. 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. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PHYSICIAN WAS EXPERIENCING SPONTANEOUS ADJUSTMENTS WITH THE STRATA VALVES. ACCORDING TO THE REPORT, HE HAD SEEN BOTH INCREASE AND DECREASE ADJUSTMENTS IN THE VALVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389796 STRATA 2 VALVE, SMALL SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1