BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3841434 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09935
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8598, SERIAL # (B)(6), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER; PRODUCT ID 8596, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER; PRODUCT ID NEU_UNKNOWN_CATH, SERIAL # UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS IMPLANTED FOR RSD (REFLEX SYMPATHETIC DYSTROPHY) AND CRPS (CHRONIC REGIONAL PAIN SYNDROME) IN BOTH THE PATIENT¿S ARMS, BOTH HIPS, AND LEFT LEG. THE PATIENT STATED THAT ¿SHE IS ON SUICIDE WATCH ABOUT EVERY 2 WEEKS BECAUSE OF HER CONDITION¿. PER THE PATIENT, THERE WAS "NO QUESTION" THAT THE PAIN PUMP WAS HELPING HER, BUT "WE BARELY CONTROL IT" WITH THE PUMP. THE PUMP KEPT THE PATIENT¿S PAIN LEVEL BETWEEN A 7 AND 9 MOST OF THE TIME. THE PATIENT HAD TERRIBLE SPASMS THROUGHOUT THE DAY AND CONFIRMED THAT THIS HAD ALWAYS BEEN THE CASE. THE PATIENT STATED THAT SHE WOULD NOT BE ALIVE IF IT WEREN'T FOR THE PUMP. THE PUMP WAS CURRENTLY DELIVERING DILAUDID WITH A BOLUS DOSE OF "8.618 A DAY...AT A MAXIMUM"; THE PATIENT USUALLY USED ABOUT 4 BOLUSES A DAY. ABOUT 2 MONTHS AGO, THEY TRIED ¿GOING UP HIGHER¿, BUT THE PATIENT WAS BACK IN THE DOCTOR¿S OFFICE AFTER 2 DAYS BECAUSE IT WAS ¿TOO MUCH.¿ THE PATIENT FELT THAT THE ONLY BAD THING WITH THE PUMP WAS THAT SHE FELL ALL THE TIME ¿BECAUSE OF THE DRUGS¿ IN THE PUMP. SOMETIMES, SHE FELL 20 TIMES A WEEK. THE REASON SHE WOULD FALL WAS BECAUSE THE PAIN WAS BEING CONTROLLED AND SHE DIDN¿T REALIZE HER LEGS WERE UNDERNEATH HER. THE FALLS HAD BEEN INTERMITTENT SINCE IMPLANT, BUT WERE DRAMATICALLY WORSE WHEN THE DRUG WAS HIGHER; SHE COULD FALL 3 OR 4 TIMES A DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318499 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention