BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED EL

    MDR report key: 507822 · Received January 21, 2004

    Report

    Report Number
    6000030-2004-00090
    Event Type
    Death
    Date Received
    January 21, 2004
    Date of Event
    December 10, 2003
    Report Date
    December 22, 2003
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HCP REPORTED THE PATIENT PRESENTED 12/2003 WITH AN INCREASE IN PAIN DUE TO AN INCREASE IN ACTIVITY. THE PUMP MEDICATION DELIVERY WAS INCREASED FROM 2.5 MG/DAILY TO 3 MG/DAILY WITH A .75 MG BOLUS GIVEN. SIX DAYS LATER, THE PATIENT EXPIRED. THE PUMP WAS REMOVED THAT SAME DAY AND THEN RETURNED TO THE MFR FOR ANALYSIS. THE PUMP WAS INTERROGATED: TELEMETRY SHOWS THE PUMP WAS RUNNING ON A SIMPLE CONTINOUS MODE OF 3 MG/DAY. THE DRUG CONCENTRATION WAS 10 MG/ML MORPHINE. THE PATIENT WAS THEN RECEIVING 0.3 ML/DAY. THE EXPECTED RESERVOIR VOLUME WAS 8.7CC AND THE ACTUAL RESERVOIR VOLUME WAS 11.5 ML LIQUID. AN AUTOPSY IS PENDING THE RESULTS OF THE PUMP ANALYSIS. THE HCP DOES NOT BELIEVE THE DEATH WAS DEVICE RELATED. A FOLLOW UP REPORT WILL BE SENT WHEN ADDITIONAL IS OBTAINED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death EXPLANTED: 2003| CATHETER MODEL 8731 LOT# B005692N61 IMPLANTED:2003