BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3873051 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11596
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    May 26, 2014
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S PUMP ¿FLIP FLOPS¿ CONSTANTLY. IT WAS REPORTED THAT THE MANUFACTURE REPRESENTATIVE TOLD THE PATIENT THAT THE SUTURES HAD COME UNDONE AND THAT THEY WOULD NEED SURGERY RIGHT AWAY TO REPLACE OR FIX IT. IT WAS NOTED THAT THE PATIENT¿S PHYSICIAN HAD TOLD THE PATIENT THAT IT WAS ¿NO BIG DEAL AND DON¿T WORRY ABOUT IT.¿ IT WAS REPORTED THAT THE PUMP STICKS OUT OF THE PATIENT¿S STOMACH LIKE AN ¿ALIEN BABY, LIKE IT IS READY TO BURST.¿ IT WAS UNKNOWN WHAT THE PUMP SYSTEM WAS INFUSING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT¿S PUMP BEEN FLIPPING SINCE LATE (B)(6) 2013. THE HEALTH CARE PROVIDER (HCP) THAT DID REFILLS FOR THE PATIENT HAD TROUBLE WITH REFILLING THE PUMP AND HAD TO HOLD THEIR HAND ON THE PUMP, THE WHOLE TIME IT WAS BEING REFILLED. THE PATIENT¿S LAST REFILL WAS (B)(6) 2014. THE FIRST 2 MONTHS POST IMPLANT THE PUMP WORKED WONDERFULLY, BUT LIFE HAD BEEN ¿HELL¿ EVER SINCE THEN. IT WAS NOTED THAT THE PUMP HAD BEEN CRITICALLY ALARMING EVERY HOUR SINCE (B)(6) 2014 WHEN THE PATIENT¿S FIANCÉ HEARD THE ALARM. THE PATIENT BEGAN HEARING IT A COUPLE OF MONTHS AGO. THE PATIENT WAS PRESCRIBED ORAL PAIN MEDICATIONS THAT THE PATIENT WAS ON WHEN IMPLANTED SO THE PATIENT DID NOT GO THROUGH WITHDRAWAL. TWO DAYS PRIOR TO REPORT, THE PATIENT WOKE UP AND THE AREA AROUND THE PUMP WAS SWOLLEN, WARM TO THE TOUCH AND RED. THE SYMPTOMS CAME ON SUDDENLY. THE PUMP WAS USED TO INFUSE BACLOFEN AND MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349424 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1