BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3926477 · Received July 10, 2014

    Report

    Report Number
    3004209178-2014-12795
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    December 3, 2009
    Report Date
    June 16, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2005 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD A CHANGE IN THERAPY EFFECT. THE PATIENT HAD BEEN ¿SO HECTIC WITH HER PAIN¿ AND LOST HER HEALTH CARE PROVIDER (HCP) LISTINGS. THE PAIN LEVEL WAS NOT AT A 10; IT WAS AN ¿11 OR 12.¿ THE HCP BEGAN CHANGING/INCREASING THE DRUG IN THE PUMP AND MAKING THE REFILL INTERVALS SHORTER ABOUT 1-2 REFILLS OR 7-8 WEEKS AGO. THE PATIENT GOT THE DRUG FASTER AND CAME INTO THE HCP¿S OFFICE FOR REFILLS MORE FREQUENTLY. THE PATIENT¿S PAIN STARTED ABOUT 4 WEEKS AGO AND THE PATIENT HAD A FALL, BUT IT WAS NOT HARD. IT WAS REPORTED, THE PUMP WAS IMPLANTED ABOUT 10 YEARS AGO (AND IT WAS LATER CLARIFIED THERE WAS A PUMP REPLACEMENT IN 2009 WHEN THE BATTERY WAS SUPPOSED TO GO DEAD). THE PATIENT GOT A CT SCAN AND SAW A HCP FOR THE FIRST TIME IN 9 YEARS. THE HCP TOLD THE PATIENT THAT THEY DID NOT GO DOWN FAR ENOUGH IN THE CT SCAN ON THE CATHETER AND ANOTHER CT SCAN WOULD NEED TO BE PERFORMED. THE SYSTEM WAS BEING USED TO DELIVER CLONIDINE, BUPIVACAINE, AND DILAUDID (HYDROMORPHONE). TWO DAYS LATER, IT WAS REPORTED, THE DOCTOR HAD BEEN CHANGING THE DOSAGE TRYING TO GIVE THE PATIENT DIFFERENT PAIN RELIEF. SINCE IMPLANT IN 2009, ABOUT A WEEK BEFORE THE PUMP IS DUE TO BE REFILLED THE PATIENT EXPERIENCED A RETURN OF PAIN WHICH GOT INCREASINGLY WORSE THE CLOSER IT GOT TO THE REFILL DATE. THIS HAD HAPPENED WITH EACH REFILL AND HAPPENED THE WEEK BEFORE THE LAST REFILL ON (B)(6). FOR THE PAST 1.5 YEARS, THE PATIENT HAD DIZZINESS WHEN SHE GOT UP AND DOWN. THE HCP TOLD THE PATIENT IT WAS THE CLONIDINE AND BUPIVACAINE CAUSING THE DIZZINESS AND LOW BLOOD PRESSURE. THE PATIENT WAS HOSPITALIZED FOR THESE SYMPTOMS OVER A YEAR AND A HALF AGO AND GOT A NEW MIXTURE OF MEDICATIONS. IT WAS NOTED, THE PATIENT WAS GIVEN A CAT SCAN FOR THE CATHETER ON (B)(6) AND EVERYTHING WAS IN ORDER. THE PATIENT THEN WENT BACK THE NEXT WEEK AND THE HCP DID SOME KIND OF SCOPE AND SENT THE PATIENT FOR ANOTHER SCAN BECAUSE, THE FIRST ONE WASN¿T LOW ENOUGH. THE SCAN WAS PERFORMED ON 2014 (B)(6) AND THE RESULTS WERE NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404192 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization