BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2974360 · Received February 22, 2013

    Report

    Report Number
    3004209178-2013-02984
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    January 28, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709SC SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTED THEY GOT SICK FROM MORPHINE. THE PATIENT WAS IN THE HOSPITAL AT THE TIME. THE PATIENT'S LEGS "STARTED SHAKING REAL BAD". THE PATIENT HAD A "HUGE WELT" THE SIZE OF A SOFTBALL OVER THE AREA WHERE THE CATHETER WENT FROM THE SPINE TO THE PUMP. THE WELT HAD BEEN THERE FOR MONTHS, WAS PAINFUL AND CAUSED SCIATIC PAIN. PATIENT DID NOT THINK IT WAS AFFECTING THE PUMP BUT WAS NOT SURE AS THE PATIENT "KEPT ON FALLING DOWN". THE PATIENT GOT "BANGED UP PRETTY BAD BECAUSE MY KNEE KEPT ON COLLAPSING, AND THAT WAS FROM THE MILITARY". THE PATIENT'S BACK AND LEGS WERE HURTING AND THEY HAD EAR PAIN. THE PATIENT DID NOT FEEL THE MEDICATION COME INTO HIS BODY. THE PATIENT HAD EXPERIENCED SOME PAIN RELIEF BUT 1-1.5 HOURS LATER THE PAIN WAS BACK. PATIENT REPORTED USING MARIJUANA "EVERY ONCE IN A AWHILE" TO HELP. THE PUMP WAS DELIVERING DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE WELT/SWELLING WAS AROUND THE PUMP CATHETER ON THE RIGHT FLANK. A CATHETER DYE STUDY WAS PERFORMED ON 2/21/13 AND RESULTS WERE THE CATHETER WAS INTACT AND PATENT. IT WAS NOTED THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND THE OUTCOME WAS INDICATED AS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77893 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization