BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3181667 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10685
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8785, LOT# N352392, IMPLANTED: (B)(6) 2013, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN WAS SUTURING THE DURA AROUND THE CATHETER DUE TO A CEREBROSPINAL FLUID LEAK. THERE WAS NO CHANGE IN DOSING OR PRODUCT. IT WAS ALSO REPORTED THAT THE CATHETER COULD NOT BE SEEN UNDER X-RAY, EXCEPT FOR THE TIP AND THE ANCHOR. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283141 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention