BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SYNCHROMED II

    MDR report key: 3554354 · Received December 10, 2013

    Report

    Report Number
    3554354
    Event Type
    Injury
    Date Received
    December 10, 2013
    Date of Event
    December 9, 2013
    Report Date
    December 13, 2013
    Manufacturer
    MEDTRONIC WORLD HEADQUARTERS
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT CAME TO OUR PAIN MANAGEMENT FACILITY FOR REFILL OF MORPHINE PUMP. ON 1110 PUMP TELEMETRY DONE - 6.3ML LEFT IN PUMP. SKIN CLEANED WITH POVIDINE IODINE, STERILE DRAPE PLACED. TEMPLATE PLACED OVER PUMP, #22 NON-CORING NEEDLE INSERTED, FELT NEEDLE TOUCH BACK OF PUMP. ABOUT 5.8ML OF MORPHINE REMOVED AND DISCARDED. NEEDLE HELD IN PLACE AND PUMP FILLED WITH MORPHINE. INITIAL 1ML INSERTED AND WITHDRAWN TO ASSURE NEEDLE PLACEMENT IN PUMP. THROUGH OUT PUMP FILL EVERY 2-3 CC, NEEDLE PLACEMENT CHECKED WITH WITHDRAWAL OF 1 CC OF MORPHINE. AT THE END OF PUMP FILL 2CC OF MORPHINE WAS WITHDRAWN AND PUT BACK IN PUMP TO ASSURE NEEDLE PLACEMENT WAS STILL IN PUMP. ON 1135 AFTER PUMP FILL PATIENT STATED THEY DID NOT FEEL VERY WELL, BP 114/62. ON 1143 111/62, PULSE 72, 02SAT 92%. ON 1147 911 CALL PLACED. ON 1150 RESPIRATIONS ASSISTED WITH MASK AND AMBUBAG BY DR. ON 1153 INTUBATED BY DR., 02SAT 33%. ON 1155 AMBULANCE STAFF ARRIVED AND TOOK OVER CARE - PATIENT TRANSPORTED TO NEARBY HOSPITAL EMERGENCY DEPARTMENT ADMITTED TO INTENSIVE CARE UNIT. DISCHARGED (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644009 MEDTRONIC SYNCHROMED II PAIN PUMP LKK MEDTRONIC WORLD HEADQUARTERS 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R