BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 1131164 · Received August 20, 2008

    Report

    Report Number
    1131164
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 18, 2008
    Manufacturer
    MEDTRONIC
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S BACLOFEN PUMP FAILED. IT WAS REPLACED AT THE TIME OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC BACLOFEN IMPLANT LKK MEDTRONIC 8637-40 NGV414269H

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention