BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202664 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00563
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 18, 2012
    Report Date
    May 18, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. PRODUCT ID: 86 3740, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: PUMP. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HCP WAS NOT ABLE TO ASPIRATE DRUG OUT OF THE PUMP RESERVOIR. AS A NEW PUMP WAS BEING PREPARED AT A PUMP REPLACEMENT PROCEDURE, STERILE WATER WAS ASPIRATED FROM THE PUMP AND 3 ML OF DRUG WAS PUT INTO THE RESERVOIR. BUT WHEN THE HCP ATTEMPTED TO ASPIRATE THE 3 ML TO PERFORM A RINSE THEY WERE NOT ABLE TO DO SO. IT WAS REPORTED THAT "AIR BUBBLES CAME OUT, SO I'M GUESSING MAYBE WE HAD SOME AIR IN THE PUMP." THE HCP CHOSE TO FILL THE REMAINING RESERVOIR CAPACITY WITH DRUG WITHOUT ASPIRATING THE 3 ML. THE PUMP WAS FILLED WITH 38 ML TOTAL. THE HCP WAS GOING TO PUT 40 ML IN THE RESERVOIR, BUT WAS ONLY ABLE TO FILL WITH 38 ML TOTAL. IT WAS REPORTED THAT THE DRUG CONCENTRATION IS CONSIDERED TO BE 97%. IT WAS REPORTED THAT ADDITIONAL ASPIRATION WAS SUCCESSFUL IN SURGERY SO THE HCP WAS "OK WITH PROCEEDING." NO PATIENT SYMPTOMS WERE REPORTED. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302318 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR