BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3201781 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11183
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    March 12, 2013
    Report Date
    June 6, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN "HIT" OR "BRUISED" A NERVE IN THE PATIENT¿S LEFT LEG DURING PUMP IMPLANT. THE LEFT LEG WAS NUMB AND TINGLING DOWN TO THE TOES. PER THE REPORTER, SOMEHOW THE PATIENT GOT AN INFECTION IN HER LEG. THE PHYSICIAN SAW THE PATIENT FOUR TIMES AND SHE HAD ROUNDS OF ANTIBIOTICS. EVENTUALLY THE PATIENT WENT TO THE ER TO FIND OUT THAT THE PHYSICIAN HAD THE PATIENT ON THE WRONG ANTIBIOTICS. THE PATIENT HAD SWELLING IN HER LEG. THE NIGHT BEFORE YESTERDAY, THE LEG SWELLED UP AGAIN, THE BOTTOM OF HER LEG WAS THE SAME SIZE AS THE TOP. THE SWELLING DIDN'T START UNTIL 4 WEEKS AFTER IMPLANT. IT WAS ALSO NOTED THAT THE PUMP WAS SITTING ON A HIP BONE, SO THE PHYSICIAN WAS PLANNING TO IMAGE AND DETERMINE IF A REVISION WAS NEEDED. THE PATIENT STILL HAD PAIN AND FELT THAT THE PUMP WAS BEGINNING TO WORK. THE PATIENT HAS BEEN DEALING WITH CHRONIC PAIN FOR THE LAST 5 YEARS. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE.

    Description of Event or Problem · 1

    FOR FURTHER CLARIFICATION IT WAS REPORTED THAT THE PUMP HAD "FELL DOWN" AND WAS SITTING ON THE PATIENT'S RIGHT HIP BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300926 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention