BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3200285 · Received July 1, 2013

    Report

    Report Number
    3004209178-2013-11147
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    June 8, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POCKET SITE WAS PAINFUL. IT WAS STATED THAT THE PATIENT WAS THIN AS SHE HAD LOST WEIGHT. A REVISION WAS PLANNED FOR (B)(6) TO MOVE THE PUMP AN INCH SUPERIOR. THE DRUG USED IN THE SYSTEM WAS UNKNOWN. FIVE DAYS LATER, IT WAS REPORTED THAT THE PUMP WAS MOVED TWO INCHES SUPERIOR AND ONE INCH LATERAL TO AVOID A BONY PROMINENCE. THERE WERE NO ISSUES WITH THE CATHETER AND A SATISFACTORY DYE STUDY WAS PERFORMED. IT WAS ALSO STATED THAT THERE WAS NEVER AN ISSUE OF ADEQUATE THERAPY. THE REPORTER WAS NOT AWARE OF THE PATIENT¿S POST-OPERATIVE STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298691 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention