BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3140689 · Received May 31, 2013

    Report

    Report Number
    3004209178-2013-08490
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 7, 2013
    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 8784, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS EXPLANTED FOR INFECTION. IT WAS ALSO NOTED THAT THE PUMP HAD REACHED THE NORMAL REPLACEMENT INDICATOR (ERI). IT WAS LATER REPORTED THAT MORPHINE WAS IN THE PUMP. IT WAS NOTED THAT THE PATIENT EXPERIENCED REDNESS AROUND THE PUMP. THE PUMP AND THE CATHETER WERE EXPLANTED IN (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT WAS DOING BETTER AS OF (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241593 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention