BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1202916 · Received October 17, 2008

    Report

    Report Number
    6000030-2008-06663
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 17, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REFILL, THE PT'S PUMP "SEEMED TO HAVE STOPPED". TELEMETRY WAS DONE SHOWING THE ESTIMATED RESIDUAL VOLUME 10.4 CC AND THE ACTUAL RESIDUAL VOLUME WAS "ABOUT" 16CC. A ROTOR STUDY WAS PERFORMED AND FOUND THE PUMP WAS NOT RUNNING. A DYE STUDY WAS PERFORMED INDICATING THE CATHETER WAS "GOOD" WHICH WAS CONFIRMED IN SURGERY. THE PUMP WAS REPLACED. THE DRUG IN THE PUMP WAS COMPOUNDED BACLOFEN AT A CONCENTRATION OF 4000 MCG/ML. DRUG ANALYSIS SHOWED THE ACTUAL CONCENTRATION WAS 4155 MCG/ML. THIS WAS 3.9% HIGHER IN CONCENTRATION THAN LABELED, BUT CONSIDERED TO HAVE PASSED AS IT WAS WITHIN THE +/-5% MARGIN. THE DRUG HAD NO PRECIPATE AND THE PH WAS 7.15, WHICH WAS SLIGHTLY ABOVE THE EXPECTED RANGE OF 5.0-7.0. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED| CATHETER MODEL 8709 LOT# J11276R11| EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT# UNK