BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3243247 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12184
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    June 28, 2013
    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

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    CORRECTION - THE PATIENT FELT LIKE THEY HAD GAINED SO MUCH WEIGHT BECAUSE THEY WERE SO IMMOBILE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEIR HEALTHCARE PROVIDER HAD TO PUT IN A NEW CATHETER IN (B)(6). PER THE MANUFACTURER¿S DEVICE REGISTRY, THE PATIENT¿S CATHETER WAS PARTIALLY REPLACED ON (B)(6) 2013. THE PATIENT NOTED THAT THE REASON FOR THE CATHETER REMOVAL WAS ¿THE PUMP WAS NOT WORKING AT ALL¿. INFORMATION REASONABLY SUGGESTED THE PATIENT WAS SPEAKING ABOUT THE CATHETER AND THEIR THERAPY. THE PUMP WAS NOT REMOVED AT THAT TIME. AFTER THE CATHETER WAS REMOVED, A PHYSICIAN STATED THAT ¿IT LOOKED LIKE FATTY TISSUE WAS ALL BUILT UP AROUND THE CATHETER, OR THAT IT WAS LEFT IN PLASTIC; THAT IT LOOKED LIKE A PIECE OF PLASTIC OR A PIECE OF FATTY TISSUE WAS PLUGGING IT¿. THEY STATED ¿IT WAS DISASTROUS BECAUSE THEY WERE REAL SICK AND THEY HAD REALLY BAD HEADACHES¿. THEY PATIENT STATED THEY COULD NOT GET IT TO GO AWAY, AND THEY WERE THROWING UP FOR SEVEN DAYS. THEY STATED THE PHYSICIAN ¿ACCIDENTALLY SLICED THEIR SPINAL CORD¿ SO THEY HAD A LOT OF FLUID COMING OUT. THE PATIENT CONFIRMED IT WAS SPINAL FLUID. THE PHYSICIAN TRIED TO DO A BLOOD PATCH, BUT THAT DID NOT WORK. THEY ENDED UP HAVING TO GO BACK IN AND STITCH IT. THE PATIENT STATED EVERY TIME THEY TOOK A BREATH IT WOULD HURT. THE PATIENT NOTED THEIR NEUROPATHY HAD GOTTEN WORSE ¿SINCE EVERYTHING¿; THAT IT WAS SO BAD THAT THEY HAD ¿CHARLIE HORSES¿ REAL BAD IN THEIR LEGS THAT WOKE THEM UP IN THE MIDDLE OF THE NIGHT. THE PATIENT HAD PAIN AND WEAKNESS IN THEIR LIMBS. THEY STATED THAT THE NEUROPATHY WAS EITHER ONE WAY OR THE OTHER; THAT IT FELT LIKE THEY WERE WALKING ON ROCKS, OR THEY FELT NOTHING AND KEPT FALLING BECAUSE THERE WAS NO FEELING IN THEIR FEET. THE MEDICATION USED WITHIN THE SYSTEM WAS MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343908 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention