BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1082482 · Received July 25, 2008

    Report

    Report Number
    3004209178-2008-04405
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 26, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING IMPLANT, THE PUMP WAS PROGRAMMED TO DELIVER MORPHINE 10 MG/ML AT LOWEST RATE OF 0.48 MG/DAY. THE PATIENT EXPERIENCED AN OVERDOSE WITH SYMPTOMS OF RESPIRATORY DEPRESSION AND SOMNOLENCE. THE PUMP WAS THEN REPROGRAMMED TO A MINIMUM RATE; THE PATIENT WAS FINE AFTERWARDS. THERE WAS NO TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL 8709 LOT# N157031011| IMPLANTED:| PROGRAMMER MODEL 8840 SERIAL# UNK| EXPLANTED: