BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3193059 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-10966
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    March 17, 2013
    Report Date
    May 30, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEW DAYS AFTER IMPLANT, ON (B)(6) 2013, THE PATIENT WAS HOSPITALIZED BECAUSE HE COULDN¿T STAND UP AND WAS CONFUSED. THE PUMP WAS RE-PROGRAMMED TO A LOWER DOSE AND THE PATIENT RESPONDED WELL TO THAT SO HE COULD STAND UP AGAIN. ON (B)(6) 2013 THE PATIENT FELL AND FRACTURED HIS PELVIS. HE WAS HOSPITALIZED FOR THREE DAYS AND WAS TRANSFERRED TO ANOTHER HOSPITAL BECAUSE ¿THEY WOULDN¿T DO ANYTHING¿. BY THE TIME HE WAS TRANSFERRED HE HAD SEVERE DEHYDRATION, ATRIAL FIB, PNEUMONIA AND A BOWEL OBSTRUCTION. HE WAS IN THE INTENSIVE CARE UNIT FOR NINE DAYS. ON (B)(6) 2013 THE PUMP WAS TURNED OFF TO SEE IF THE PAIN PUMP AND THE MEDICATIONS AT THE HOSPITAL WERE CAUSING THE PATIENT TO GET CONFUSED. FOUR TO FIVE DAYS LATER THE PATIENT STARTED HAVING PAIN AGAIN. ON (B)(6) 2013 THE PUMP WAS TURNED BACK ON. IT WAS UNKNOWN IF THE PATIENT WENT THROUGH WITHDRAWAL AS HE WAS IN THE HOSPITAL AT THE TIME. PER THE REPORTER, THE ISSUES THAT THE PATIENT HAD COULD HAVE BEEN DUE TO THE PO OR IV MEDS THAT WERE ADMINISTERED. AN MRI OF THE SPINE WAS SCHEDULED FOR (B)(6) 2013 TO DETERMINE IF THE PATIENT HAD A PINCHED NERVE. IT WAS NOTED THAT THE PATIENT BEGAN HAVING PAIN IN THE CALF OF THE LEFT LEG APPROXIMATELY TWO WEEKS PRIOR WHEN HE FELL AND ENDED UP IN THE HOSPITAL. THIS WAS UNRELATED TO THE DRUG INFUSION SYSTEM. X-RAYS WERE DONE OF THE PATIENT¿S KNEE AND ANKLE AND THERE WERE NO ISSUES FOUND. PER THE REPORTER, THEY BELIEVE THAT THERE MAY BE "A DROP OF MORPHINE" WITH THE MARCAINE IN THE PUMP. THE DEVICE SYSTEM WAS USED TO DELIVER MARCAINE AND MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292759 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Hospitalization| R