BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2061954 · Received April 5, 2011

    Report

    Report Number
    3007566237-2011-02605
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    January 1, 2008
    Report Date
    March 25, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOR THE LAST THREE YEARS, THE ACTUAL RESIDUAL VOLUME WAS 5 ML MORE THAN THE EXPECTED VOLUME AT EVERY REFILL. CLINICALLY, THE PT WAS DOING WELL; NO CHANGES IN THERAPY NOTED THROUGHOUT THE REFILL CYCLE. THE PATIENT AND FAMILY WERE CONCERNED ABOUT THE DRUG COST/WASTE AND THE PUMP FUNCTION. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL 2,000 MCG/ML AT APPROX 1700 MCG/DAY. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR EXPLANTED:| CATHETER: MODEL 8709, LOT# J10955R37| IMPLATNED: