BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3211559 · Received July 8, 2013

    Report

    Report Number
    3007566237-2013-02280
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    June 13, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8781, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS DOING FINE AFTER THE CATHETER, TUBING AND RESERVOIR WERE EMPTIED AND REPLACED THE DRUG WITH SALINE AND PUT THE PUMP ON MINIMUM RATE. THIS WAS DONE THE DAYS FOLLOWING THE IMPLANT. THE PLAN WAS TO SLOWLY START UP THE BACLOFEN THERAPY AGAIN. THE DAILY DOSE OR CONCENTRATION WAS NOT DECIDED YET AND IT REMAINS TO BE SEEN TO AFTER THE SUMMER WHAT THE EFFECT MIGHT BE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT WAS DOING ¿FINE¿ WITHOUT THE BACLOFEN, AS OF 30-AUG-2013. THE DRUG GAVE HIM SIDE EFFECTS, SO MORPHINE WAS TRIED INSTEAD. THE PUMP AND CATHETER WERE WORKING FINE. THE PUMP WAS RUNNING AT MINIMAL RATE WITH SALINE.

    Description of Event or Problem · 1

    IT WAS REPORTED A PRIMING BOLUS WAS PERFORMED AT 1530 IN THE AFTERNOON IMMEDIATELY AFTER SURGERY. THE PRIMING BOLUS WAS 0.395 ML. DURATION: 2 HOURS. APPROXIMATELY TWO HOURS LATER THE PATIENT WENT OUT FOR AIR AND DIDN'T COME BACK IN. THE PATIENT HAD LOST THE ABILITY TO STAND ON HIS FEET AND GOT MORE TIRED. OVERDOSE SYMPTOMS WERE INDICATED AS LOST STRENGTH IN LEGS, TIRED. IT WAS INDICATED THERE WAS NO ¿DRUG IN PATH¿. CONCENTRATION OF 2000 MCG/ML EQUALS 790 MCG IF IT HAD BEEN DRUG IN PATH. THE PHYSICIAN SUSPECTED A PRIMING BOLUS ISSUE AS DRUG AND FACTORY FLUID IN PUMP TUBING AND CEREBROSPINAL FLUID IN CATHETER COULD BE MIXED WITH THE DRUG. THE PATIENT WAS BROUGHT IN ¿AFTER A WHILE TO BED.¿ THE DOCTOR PROGRAMMED THE MINIMAL RATE ON THE PUMP. THE PATIENT SLEPT WELL THAT NIGHT. THE NEXT DAY THE PATIENT WAS BACK TO HABITUAL STATE. THE PUMP WAS KEPT AT A MINIMAL RATE. IT WAS PLANNED TO PERFORM AN ADJUSTMENT OF DAILY DOSE THE FOLLOWING WEEK. THE PATIENT STATUS WAS ALIVE, NO INJURY, NO ADVERSE EVENT. THE PUMP WAS DELIVERING COMPOUNDED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311410 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R