BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 14547240 · Received May 31, 2022

    Report

    Report Number
    3004209178-2022-06923
    Event Type
    Injury
    Date Received
    May 31, 2022
    Date of Event
    May 25, 2022
    Report Date
    May 31, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169630505
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING MORPHINE VIA AN IMPLANTED PUMP. IT WAS REPORTED THAT THE PUMP HAD BEGUN TO TURN PERPENDICULAR TO THE PATIENT¿S SKIN BECAUSE THE PATIENT GAINED WEIGHT. THE HCP HAD DIFFICULTY FILLING THE PUMP AND FEARED THAT THE PUMP WOULD FLIP COMPLETELY, SO DECIDED TO REVISE THE POCKET AND MOVE THE PUMP FROM THE LRQ (LOWER RIGHT QUADRANT) TO THE PATIENT¿S BACK WHERE THE PUMP WOULD BE SECURED. AS A RESULT, THE EXISTING CATHETER HAD TO BE REVISED. SUCCESSFUL ASPIRATION WAS ACHIEVED, AND THE PATIENT WAS DOING WELL. THE ISSUE WAS NOTED TO BE RESOLVED, AND IT WAS INDICATED THAT THE HCP HAD NO FURTHER INFORMATION TO PROVIDE REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1599133 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169630505

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention