BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3201532 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04790
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    February 24, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE CATHETER; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS REPLACED 3 YEARS AGO IN (B)(6) 2009, THE PATIENT STARTED HAVING SENSATIONS THAT WERE DESCRIBED AS ¿THE ITCHY TWITCHES¿. BY (B)(6) 2009, THE PATIENT ¿BECAME VERY ILL¿ AND WAS THOUGHT TO HAVE GUILLAIN BARRE SYNDROME (GBS) ALTHOUGH ¿NONE OF THE TESTING SUPPORTED IT¿. THE PATIENT ¿BECAME VERY WEAK¿ AND HAD VISION DISTURBANCES, LOW BLOOD PRESSURE (BP), AND A BURNING SENSATION OVER HIS BODY. IT WAS REPORTED THAT 8 WEEKS LATER THE PATIENT HAD ¿A VERY SIMILAR SPELL¿, AND AS TIME WENT ON, THE PATIENT BEGAN TO HAVE ¿THESE TWITCHING SPELLS¿ THAT WOULD LAST FOR HOURS AND HOURS. THE PATIENT WAS THEN DIAGNOSED WITH SPINAL MYOCLONUS. AFTER NO IMPROVEMENT AND MORE FREQUENT 'SPELLS', THE PATIENT SAW A DIFFERENT PHYSICIAN WHO BELIEVED THAT MOST LIKELY ALL THIS TIME THE PATIENT HAD BEEN HAVING PERIODS OF BACLOFEN WITHDRAWS DUE TO A ¿FAULTY CATHETER¿. THE PATIENT IS NOW ON ORAL BACLOFEN, AND IT HAS BEEN NEARLY A MONTH SINCE THE LAST ¿SPELL¿. THE REPORTER WAS QUESTIONING WHY IT WOULD IT TAKE THAT LONG TO DETERMINE THAT BACLOFEN WITHDRAW WAS THE MOST LIKELY PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303189 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00009 YR Other| R