BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2013249 · Received March 6, 2011

    Report

    Report Number
    2013249
    Event Type
    Malfunction
    Date Received
    March 6, 2011
    Date of Event
    February 4, 2011
    Report Date
    March 6, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE EXPLANTED DUE TO SUSPECTED FAILURE. INTRACTABLE SPASTICITY, BACLOFEN PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR