BEUDAMED
    FDA Adverse Event Summary report: N

    SYNCHROMED

    MDR report key: 3070006 · Received April 15, 2013

    Report

    Report Number
    3070006
    Date Received
    April 15, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC INC
    Product Code
    LKK
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    PUMP REPLACED FOR END OF LIFE OF PUMP. END OF LIFE EXPECTANCY, SYNCHROMED PUMP 8737-20.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?MANAGE SPASTICITY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161168 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC INC 8737-20 *

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR NO OTHER THERAPIES