BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4236682 · Received November 7, 2014

    Report

    Report Number
    3004209178-2014-21144
    Event Type
    Injury
    Date Received
    November 7, 2014
    Report Date
    October 15, 2014
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8731SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), EXPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD DYE PUT INTO HER PUMP ON (B)(6) 2014 AND THEY SAID IT WAS NOT GOING TO THE RIGHT PLACE AND ¿IT WAS NOT RUNNING RIGHT.¿ THE PATIENT WAS CONCERNED BECAUSE HER BACK HAD ALWAYS HURT WHEN SHE WAS ON HER FEET, BUT IT SEEMED LIKE IT HAD BEEN GETTING WORSE SINCE THERE WAS CONCERN ABOUT IT GOING TO THE RIGHT PLACE. REGARDING THE PUMP THERAPY, THE PATIENT WAS ¿NOT SURE IF IT¿S EVER DONE AS GOOD AS IT SHOULD." THE PATIENT COULD SIT ON HER BOTTOM ALL DAY LONG AND "IT DID NOT HURT,¿ BUT WHEN SHE WAS ON HER FEET IT BURNED ¿LIKE THERE WAS A NERVE ON FIRE.¿ THE PATIENT HAD NOT HAD ANY WITHDRAWAL SYMPTOMS IN THE LAST TWO MONTHS, AND SHE WAS TOLD THAT HER BODY WAS STILL GETTING THE DRUG FROM THE PUMP, BUT "IT WAS NOT GOING TO THE RIGHT PLACE, WHICH WAS INSIDE HER SPINE." IT WAS FURTHER REPORTED IT STARTED TO GET WORSE A COUPLE OF MONTHS AGO, AND THAT WAS WHEN THEY LAST REFILLED IT. ACCORDING TO THE PATIENT¿S PUMP PRINT OUT THE LAST CHANGE WAS MADE ON (B)(6) 2014 AND THEY DID AN INCREASE OF 10%. THE PATIENT¿S BLOOD PRESSURE HAD STARTED TO SPIKE EVERY FEW DAYS SINCE (B)(6) 2014 AND IT WAS 213/113. IT WAS NOTED THE DRUGS IN HER PUMP HAD BEEN CHANGED, ALTHOUGH SHE HAD ALWAYS HAD DILAUDID AND ¿THEN THEY PUT IN A MUSCLE RELAXER, AND THE WAY SHE UNDERSTOOD IT WAS THAT THE THIRD ONE WAS A MUSCLE RELAXER.¿ THE PATIENT WAS TO GO BACK FOR A REFILL ON (B)(6) 2014. THE PUMP WAS BEING USED TO DELIVER BUPIVACAINE, BACLOFEN, AND DILAUDID. INTERVENTION, OUTCOME, AND THE CAUSE OF THE EVENT WERE NOT REPORTED. FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE CATHETER HAD DISLODGED. THEY THOUGHT IT HAPPENED WHEN THE PATIENT FELL; THE PATIENT HAD FALLEN SEVERAL TIMES SINCE IMPLANT. AN "ULTRASOUND OR ANOTHER TEST" WAS DONE AND THE DISLODGEMENT WAS SEEN. PER THE PATIENT, "I WAS COMPLAINING IT WAS GIVING NO RELIEF AT ALL AND IT HADN'T BEEN FOR QUITE A WHILE, I THINK OVER A YEAR, 2 YEARS MAYBE". THE PUMP AND CATHETER WERE REPLACED. THE PUMP "WAS UP SO HIGH UNDER MY RIB THAT WHEN I'D SIT DOWN IT, I LOST SOME WEIGHT AND IT GOT TO SLIDE UP UNDER MY RIB". THE NEW PUMP WAS IMPLANTED DOWN LOWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716812 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention