BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3200024 · Received July 1, 2013

    Report

    Report Number
    3007566237-2013-02164
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    June 7, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    A REPRESENTATIVE REPORTED A PUMP REPLACEMENT WAS GOING TO BE PERFORMED ON THE DAY OF THE REPORT, AND THE PATIENT¿S POCKET WAS GOING TO BE REVISED. IT WAS THOUGHT THE PATIENT¿S PUMP WAS BEING REPLACED BECAUSE ¿THERE WAS SO MUCH SWELLING AND BLOOD IN THE POCKET¿ THAT THE PHYSICIAN WAS GOING TO DO SURGERY ANYWAY. THE MEDICATIONS USED WITHIN THE SYSTEM WERE MORPHINE AND BUPIVACAINE. THE PATIENT¿S EARLY REPLACEMENT INDICATOR WAS 13 MONTHS. THE REPRESENTATIVE LATER REPORTED THAT THE POCKET REVISION WAS PERFORMED AND THEY ¿MOVED IT OVER¿. THE PATIENT USED A POUCH WITH THEIR PUMP. THEY THOUGHT THAT ¿MAYBE THE POUCH MIGHT HAVE BEEN SOME OF THE PROBLEM,¿ BUT THE PATIENT¿S POUCH WAS NOT REPLACED. THEY NOTED THAT THE PHYSICIAN TOOK OUT A ¿LOT OF BLOOD¿ AND THERE WAS ¿QUITE A BIT¿. THE DRUG CONCENTRATION AND DAILY DOSE WERE KEPT THE SAME. THE PATIENT LEFT THE OR ¿FINE¿ AND STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298526 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention