BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3202683 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04822
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 15, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ALLERGIC REACTION TO MORPHINE. MORPHINE CAUSED THE PATIENT TO HAVE ¿ATTACKS¿ ON HIS RESPIRATORY SYSTEM, HIS STOMACH AND COLON WOULD SHUTDOWN, WAS NAUSEATED, AND WOULD GET RASHES. THE PATIENT STATED HE TAKES COMPAZINE AND BENADRYL TO RELIEVE THE ALLERGIC REACTION. HE HAD BEEN HOSPITALIZED DUE TO THIS EVENT. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. THE PATIENT OUTCOME WAS UNKNOWN AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302834 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization