BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1061483 · Received June 13, 2008

    Report

    Report Number
    2182207-2008-03251
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 16, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A VOLUME DISCREPANCY WAS REPORTED FOR THE PT'S PUMP. THE ESTIMATED RESERVOIR VOLUME WAS 2.1 ML WHILE THE ACTUAL RESERVOIR VOLUME WAS 18 ML. THERE WERE NO PROMPTS OF A MOTOR STALL OR ALARMS WHEN THE PUMP WAS INTERROGATED; THE LOGS APPEARED NORMAL. THE PT WAS EXPERIENCING TIGHTNESS. IN 2008, IT WAS REPORTED THAT AN X-RAY HAD BEEN TAKEN AND THERE WERE NO PROBLEMS FOUND. THE PT WAS PROGRAMMED TO RECEIVE A THERAPEUTIC BOLUS AND WAS REPORTED TO HAVE A SLIGHT IMPROVEMENT, OR NOTICEABLE EFFECT. ON TWO DAYS LATER, IT WAS REPORTED THAT THE PT WAS "MORE STIFF." THE CONCENTRATION AND DAILY DOES OF BACLOFEN BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention EXPLANTED:| PROGRAMMER MODEL 8840| CATHETER MODEL 8709