BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3961799 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13608
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    July 7, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8703W, LOT# L39095, IMPLANTED: (B)(6) 1997, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PUMP WAS RUNNING AT ¿90% SPEED¿ IT PUMPED FINE, BUT WHEN IT WAS TURNED UP ALL THE WAY TO 100%, ALL OF A SUDDEN THE FUNCTIONALITY OF THE PUMP DROPS. THE PUMP WORKED WHEN THE PATIENT WAS GETTING 12 MILLILITERS (ML) AND 13 ML PER DAY, BUT WHEN THE PUMP WAS TURNED UP TO 15 ML PER DAY THE PUMP DROPPED OFF IN FUNCTION. THE PUMP WAS TURNED UP TO 15 ML PER DAY SHORTLY AFTER IMPLANT. THE PUMP DOSE HAD TO BE TURNED UP TWICE AFTER IMPLANT BEFORE THE PAIN LEVEL WENT DOWN. THE PUMP WAS TURNED UP TO 15 ML PER DAY AND THE PAIN LEVEL HAD BEEN SLOWLY COMING BACK AND THE PATIENT WAS GETTING A REAL SHARP STABBING PAIN AGAIN. THE PUMP WAS PROGRAMMED SO THE PATIENT SHOULD HAVE BEEN GETTING 15 MILLILITERS PER DAY, BUT THE PATIENT ONLY GOT 13 MILLILITERS PER DAY. THERE WAS MORE DRUG IN THE RESERVOIR THAN EXPECTED. THE PATIENT WENT IN EVERY 3 WEEKS AND THE LAST 2 OR 3 TIMES, THERE HAD BEEN MORE MEDICATION IN THE RESERVOIR THAN EXPECTED. SLOWLY THERE HAD BEEN MORE MEDICATION LEFT IN THE RESERVOIR. IT WAS NOTED THE CONCENTRATION OF THE MEDICATION IN THE PUMP WAS ALWAYS THE SAME AS THE MEDICATION IN THE PUMP. THE DOSE WHEN THE ISSUES OCCURRED WAS 1.5 MILLIGRAMS (MG) PER DAY AND/OR 15 ML PER DAY. THE SYSTEM WAS BEING USED TO DELIVER DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439284 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR