BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2972794 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-02962
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 26, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8709SC, SERIAL# (B)(4). PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING PUMP IMPLANT IN 2011, THE PATIENT GAINED A LOT OF WEIGHT. DUE TO THE WEIGHT GAIN, THE PATIENT UNDERWENT SURGERY IN (B)(6) 2012 AT WHICH TIME THE PUMP WAS REMOVED, FAT FROM BEHIND THE PUMP WAS REMOVED, THE PUMP WAS RE-IMPLANTED, FAT WAS PUT BACK ON THE PUMP AND THE INCISION WAS CLOSED. ABOUT TWO WEEKS LATER THE PATIENT DEVELOPED A (B)(6) INFECTION IN HIS RIGHT LEG. A HEALTHCARE PROVIDER (HCP) TOLD THE PATIENT THAT HE MAY HAVE CONTRACTED THE (B)(6) AT AN OUTPATIENT CLINIC AND IT COULD HAVE TRAVELED TO HIS RIGHT LEG. THE PATIENT STATED THAT BY (B)(6) 2012 HIS RIGHT LEG "SWELLED UP BIGGER THAN A WATERMELON." THE PATIENT PRESENTED TO THE EMERGENCY ROOM (E.R.) AND WAS GIVEN IV MORPHINE. THE PATIENT UNDERWENT SURGERY TO REMOVE THE (B)(6) AND (B)(6) OF INFECTION WAS DRAINED FROM HIS RIGHT LEG. THE PATIENT AWOKE IN THE INTENSIVE CARE UNI T (ICU) THREE DAYS LATER. THE PATIENT STATED THAT THE INCISION FROM THE SURGERY WAS 11.5 INCHES LONG AND FOUR FINGERS DEEP. THE PATIENT WAS PLACED IN A NURSING HOME FOR THREE MONTHS FROM (B)(6) 2012 AND WAS RELEASED (B)(6) 2013. THE PATIENT WAS CURRENTLY AT HOME AND COULD NOT MOVE OR WALK BECAUSE HE COULD NOT MOVE HIS RIGHT LEG. THE PATIENT STATED THAT EVERY TIME HE MOVED THE INCISION WOULD RIP OPEN. THE INCISION WAS NOT STAPLED SHUT BECAUSE THEY WANTED THE WOUND TO HEAL FROM THE INSIDE OUT. THE PATIENT HAD NO PAIN MANAGEMENT FOLLOWING RELEASE FROM THE NURSING HOME EXCEPT FOR THE PUMP THERAPY WHICH DID NOT COVER THE PATIENT'S PAIN IN HIS HIPS, KNEES, ANKLES AND RIGHT SHOULDER THAT WERE CAUSED BY A PAST MOTORCYCLE ACCIDENT. THE DEVICE SYSTEM WAS USED TO DELIVER PRIALT, CLONIDINE AND DILAUDID. IT WAS LATER REPORTED THAT THE INCISION FROM THE SURGERY HAD CLOSED TO ABOUT AN INCH LONG AND ABOUT TWO CENTIMETERS DEEP. THE PATIENT WAS USING A WALKER TO MOVE. THE PATIENT CONTINUED TO SEEK PAIN MANAGEMENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75589 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R