BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3203528 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-02827
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    July 5, 2012
    Report Date
    July 5, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL #(B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IN AN ER WAS EXPERIENCING AN INCREASE IN PAIN AND STATED THAT THEIR ¿PUMP IS NOT WORKING.¿ THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306167 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR