BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3201686 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-00836
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    February 21, 2012
    Report Date
    February 21, 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 Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO HAD THE PUMP FOR ABOUT A MONTH AND A HALF WAS TAKING OTHER BREAKTHROUGH MEDICATION BECAUSE THE PUMP WAS NOT ¿WORKING.¿ THE PATIENT WAS PAIN-FREE AND THE PUMP WAS WORKING ¿BEAUTIFULLY¿ AFTER IMPLANT, BUT THE PATIENT¿S REFLEX SYMPATHETIC DYSTROPHY (RSD) WAS COMING BACK. IT WAS REPORTED THAT THE PUMP WAS DISCONNECTED OR LEAKING. THE DOSE WAS INCREASED, BUT ¿IT ONLY LASTED ABOUT A WEEK OR SOME SHORT PERIOD OF TIME.¿ IT WAS LATER REPORTED THAT THIS WAS A ¿FALSE ALARM.¿ THERE WERE NO ISSUES WITH THE PUMP, AND IT WAS WORKING ¿VERY WELL.¿ 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
    301635 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR