BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3203502 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-02645
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    July 26, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    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 8840, LOT# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 8711, LOT# J11386R34, IMPLANTED: (B)(6) 2003, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED WITHDRAWAL EVERY TIME THE PATIENT HAD A DYE STUDY OR A PUMP REPLACEMENT THAT REQUIRED CATHETER PRIMING. THE CATHETER LENGTH HAD BEEN AN ESTIMATE AND IT WAS BELIEVED TO BE INACCURATE. ON THE DATE OF THIS REPORT THE PATIENT WAS GETTING A CATHETER DYE STUDY DONE AND THE CATHETER NEEDED TO BE PRIMED. IT WAS PLANNED TO GIVE THE PATIENT AN EXTRA BOLUS TO HELP WITH THE PATIENT¿S WITHDRAWAL TREND. THE OUTCOME OF THEIR TROUBLESHOOTING WAS UNKNOWN. THE PUMP WAS DELIVERING LIORESAL (BACLOFEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301453 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Other