BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3931882 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-12960
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THEY HEALTHCARE PROFESSIONAL (HCP) WAS ABLE TO ASPIRATE THE RESERVOIR BUT, WAS UNABLE TO FILL IT. IT WAS NOTED THERE WERE TWO PREVIOUS REFILLS WHERE THEY WERE ONLY ABLE TO FILL IT WITH 20 ML OF DRUG ((B)(6) 2014 AND (B)(6) 2013). THE PUMP WAS IMPLANTED BY ANOTHER HCP AND THE PUMP WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411098 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR