BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3170956 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10411
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    May 21, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1150-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER; PRODUCT ID 8590-1, LOT# N155211, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY; PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT TWO MONTHS AGO, AT THE PATIENT¿S LAST REFILL IN (B)(6), THEY TURNED UP THE PATIENT¿S PUMP DOSE QUITE A BIT BECAUSE THE PATIENT¿S SPASTICITY WAS ¿SO BAD¿. SHE HAD SPASTICITY IN HER LEGS AND THIGHS; IT WAS GETTING SO BAD THAT IT WAS AFFECTING HER GAIT, SO THEY DECIDED TO GIVE THE PUMP "A PRETTY GOOD JUMP" BECAUSE THEY HADN¿T DONE ANYTHING WITH THE DOSE FOR A WHILE. FOLLOWING THAT, THE PATIENT STARTED HAVING PAIN IN HER BACK, RIGHT AT HER SPINE WHERE THE CATHETER WENT IN; IT RADIATED TO HER HIPS. INITIALLY THEY THOUGHT IT WAS A PULLED MUSCLE AND THEY DECIDED TO TURN THE PUMP UP AGAIN. SINCE THAT TIME THEY HAD TURNED THE DOSE UP A COUPLE OF MORE TIMES BECAUSE HER HIPS WERE REALLY BAD NOW; THEY WERE REALLY TIGHT. EVERY TIME THEY TURNED IT UP IT JUST SEEMED LIKE IT GOT A LITTLE BIT WORSE AND A LITTLE BIT WORSE. THE PATIENT¿S PRIMARY PHYSICIAN HAD ORDERED AN MRI BECAUSE THEY HAD BEE N TREATING THE PATIENT FOR THE BACK PAIN AND THEY HAD DONE EVERYTHING THEY COULD; THEY TRIED SEVERAL THINGS INCLUDING SEVERAL MEDICATIONS, THERAPY, HEAT, ICE, ALEVE AND IT WASN¿T GETTING ANY BETTER, IT WAS PROGRESSIVELY GETTING WORSE, SO THEY WANTED TO RULE OUT AN INFLAMMATORY MASS AT THE CATHETER TIP VIA AN MRI. THE PATIENT WAS HAVING DIFFICULTY WITH THE IMAGING COMPANIES IN HER AREA; THEY WERE ¿SHYING AWAY BECAUSE THEY CAN¿T DO IT BECAUSE IT¿S RIGHT OVER THE PUMP¿. THE PATIENT TOLD THEM THAT SHE HAD MULTIPLE MRIS SINCE THE PUMP WAS IMPLANTED; THEY WERE OF HER HEAD AND NECK BECAUSE SHE HAD MS (MULTIPLE SCLEROSIS) AND THAT SHE WAS PLANNING TO HAVE THE PUMP CHECKED BY HER PUMP MANAGING PHYSICIAN FOLLOWING THE MRI. THE PUMP WAS DELIVERING BACLOFEN ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO INDICATED THAT THE PATIENT RECEIVED GOOD RELIEF AND THE PUMP WORKED FINE, BUT BEGINNING IN 2010 THE PATIENT BEGAN HAVING LOW BACK PAIN AND PAIN IN THE LEFT LEG. THE PATIENT HAD WORKED HER HEALTHCARE PROVIDER TO DETERMINE WHAT THE ISSUE WAS AND TRIED TO TREAT THE PAIN. IN (B)(6) 2015, IT HAD BEEN DETERMINED THAT THE PATIENT WAS INTOLERANT TO THE INTRATHECAL BACLOFEN. WHEN THE DOSE WAS INCREASED, THE PATIENT EXPERIENCED MORE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271069 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Other