BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1061524 · Received June 17, 2008

    Report

    Report Number
    3004209178-2008-03298
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (SEE SCANNED PAGE).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A VOLUME DISCREPANCY AT FIRST PUMP REFILL. THE EXPECTED RESERVOIR VOLUME WAS 3.3 ML WHILE THE ACTUAL RESERVOIR VOLUME WAS 13.0 ML. THE PT WAS STILL IN THE DOSE TITRATION PHASE AND STILL HAD TIGHTNESS. THE CONCENTRATION AND DAILY DOSE OF BACLOFEN BEING DELIVERED VIA THE PUMP WERE NOT PROVIDED. DEVICE TROUBLESHOOTING WAS BEING CONSIDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention PROGRAMMER: MODEL 8840| IMPLANTED| EXPLANTED| CATHETER: MODEL 8709