BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5679014 · Received May 25, 2016

    Report

    Report Number
    3004209178-2016-10285
    Event Type
    Injury
    Date Received
    May 25, 2016
    Date of Event
    January 1, 2014
    Report Date
    May 25, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE CONSUMER REGARDING A PATIENT RECEIVING INTRATHECAL CLONIDINE, MARCAINE, AND FENTANYL. THE INDICATIONS FOR USE WERE NON-MALIGNANT PAIN AND POST LUMBAR LAMINECTOMY SYNDROME. THE PATIENT BEGAN EXPERIENCING EXTREME PAIN IN THEIR LEGS AND WEAKNESS IN 2014, AND IT HAD BEEN GETTING WORSE. THE PATIENT WAS SO WEAK HE COULD BARELY WALK UP AND DOWN STEPS. THE PATIENT WAS HAVING EXTREME PAIN IN HIS LEGS; STATING HIS RIGHT LEG WAS WORSE WITH PAIN FROM THE BACK OF HIS HIP ALL THE WAY DOWN. THE PATIENT¿S LEFT LEG WAS HAVING PAIN FROM ABOVE THE KNEE DOWN. THE PATIENT¿S WHOLE BODY HURT (SHOULDER, ARMS, NECK). THE PATIENT SOMETIMES CONSIDERED GOING TO THE EMERGENCY ROOM (ER). THE PATIENT BROKE HIS RIGHT TOE ON (B)(6) 2015, AND HIS FOOT PAIN GOT WORSE. THE PATIENT NOTED THAT PART OF THE REASON HE COULD HAVE BEEN EXPERIENCING THIS PAIN WAS HIS FOOT (HAS BONE SPURS IN BIG RIGHT TOE; GANGLION WATER CYSTS UNDERNEATH HIS BIG TOE). THE PATIENT WAS HAVING FOOT SURGERY ON (B)(6) 2016 TO REMOVE PART OF IT. BACK WHEN THIS PAIN STARTED TO GET WORSE, THE HCP PRESCRIBED 1000 (660/10 MG) VICODIN PER DAY 3X A DAY AND PUT THE PATIENT ON A MORPHINE TABLET 3X A DAY TO TRY WEANING THE PATIENT OFF ORAL VICODIN. THE PATIENT COULD NOT TAKE 3 PILLS A DAY AND WAS GIVEN A MONTH¿S SUPPLY THAT LASTED HIM 3 MONTHS AND DID REDUCE HIS VICODIN USE. WHEN HE TOOK THE ORAL VICODIN, HE WAS MUCH BETTER, AND HE KNEW THAT HIS PUMP MEDICATION WAS MORE POWERFUL THAN ORAL PRESCRIPTIONS. THE PATIENT¿S ORAL PAIN MEDS WERE STOPPED, AND HE STILL HAD A FEW LEFT FROM 2-2.5 YEARS AGO (WHENEVER THAT WAS). THE PATIENT¿S PAIN WAS SEVERE (B)(6) 2016 (2 WEEKS AGO FROM (B)(6) 2016), AND HE COULD NOT STAND IT. THE PATIENT TOOK 1-1.5 VICODIN PILLS FOR 3 DAYS. FOR THOSE 3 DAYS, THE PATIENT FELT BETTER BUT WAS STILL IN PAIN. THE PATIENT HAD A CT SCAN A WEEK AGO (FROM (B)(6) 2016) THAT SHOWED HIS ATHRITIS WAS WORSE. THE PATIENT HAD ATHRITIS (PREEXISTING CONDITION) FOR OVER 30 YEARS. THE PATIENT WAS SUPPOSED TO SEE THE HEALTH CARE PROVIDER (HCP) ON (B)(6) 2016 FOR A PUMP ADJUSTMENT. THE PATIENT¿S PAIN PUMP WAS SUPPOSED TO BE REPLACED ON THE (B)(6) 2016 DUE TO LONGEVITY. THE HEALTH CARE PROVIDER (HCP), WHO WAS TO IMPLANT THE NEW PUMP, WAS CHECKING EVERYTHING AGAIN AND MAY KEEP THE PATIENT IN THE HOSPITAL A COUPLE OF DAYS MORE. THE PATIENT THOUGHT THE CATHETER HAD BEEN CHECKED TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335641 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other