BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II 8637-40

    MDR report key: 1726603 · Received June 15, 2010

    Report

    Report Number
    MW5016341
    Event Type
    Death
    Date Received
    June 15, 2010
    Report Date
    June 15, 2010
    Product Code
    LKK
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN (B) (6) 2009, PT HAD AN EXTERNAL PAIN PUMP PLACED ON A TRIAL BASIS. HE IS ALLERGIC TO MORPHINE, THUS DOCTORS SUBSTITUTED DILAUDID AND BIVICAINE. ON FIRST DAY, HE WAS DIZZY, ITCHY AND HAD PROBLEMS URINATING. HE RETURNED TO THE DOCTOR, WHO TURNED THE PUMP OFF AND CUT THE DOSE OF PAIN MEDICATION IN HALF. HE RETURNED HOME AND STILL HAD PROBLEMS URINATING AND CONTINUED TO BE ITCHY. THE SECOND DAY OF THE LOWER DOSE, HE FELT BETTER AND EXPERIENCED 75% PAIN REDUCTION. THE THIRD DAY, THEY REMOVED THE TRIAL PUMP. ON (B) (6) 2009, THE PT HAD THE INTERNAL PUMP IMPLANTED WITH THE MEDICATION DOSE THE SAME AS THE REDUCED AMOUNT IN THE EXTERNAL TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II 8637-40 MEDTRONIC SYNCHROMED DRUG INFUSION SYSTEM LKK 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death