BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4180556 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19885
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1060-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 8590-1, LOT# N454333, IMPLANTED: 2014-(B)(6), PRODUCT TYPE ACCESSORY. PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2014-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS INDICATED THAT, WHILE REFILLING THE PUMP, A PARTIAL POCKET FILL OCCURRED WITH 3ML OF THE MEDICATION GOING UNDER THE SKIN. THE HEALTHCARE PROVIDER (HCP) WANTED TO PROGRAM THE PUMP TO MINIMUM RATE AND KEEP IT THERE FOR THIRTY MINUTES WHILE MONITORING HER. HE THEN INDICATED THAT HE WAS GOING TO RESTART THE PUMP IN TWO DAYS. IT WAS CONFIRMED THAT 15ML OF THE DRUG WAS IN THE PUMP. THE HCP FELT THAT IT WAS A LITTLE HARDER WHEN HE WAS TRYING TO FILL, THEN HE STOPPED PUSHING. AFTER VERIFYING THE POSITION, HE WAS ABLE TO INJECT EVERYTHING BACK IN, ASPIRATING 5ML TO ENSURE HE WAS IN THE RESERVOIR. THE DEVICE SYSTEM WAS BEING USED TO DELIVER BUPIVACAINE AND MORPHINE. THERE WERE NO PATIENT SYMPTOMS REPORTED AND THE OUTCOME OF THE EVENT HAD YET TO BE REPORTED. FURTHER FOLLOW-UP WAS BEING REQUESTED TO OBTAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663276 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR