BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3936303 · Received July 15, 2014

    Report

    Report Number
    3004209178-2014-13050
    Event Type
    Injury
    Date Received
    July 15, 2014
    Report Date
    June 26, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1150-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2001 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PUMP HAD BEEN DELIVERING DILAUDID 20 MILLIGRAMS (MG) PER MILLILITER (ML) FOR ABOUT 10 YEARS. IT WAS CHANGED TO 10 MG/ML FOR APPROXIMATELY 2 YEARS DUE TO THE POSSIBILITY OF INFLAMMATORY MASS OR GRANULOMA. ABOUT A YEAR AGO, IT WAS CHANGED AGAIN TO 15 MG/ML WHICH WAS THE CURRENT CONCENTRATION. THE PUMP ALSO DELIVERED CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412519 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other