BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SYNCHROMED II

    MDR report key: 2232227 · Received August 25, 2011

    Report

    Report Number
    MW5021929
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 25, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC MORPHINE IMPLANTABLE INFUSION PUMP NOT FUNCTIONING AS INTENDED. PT UNDERWENT ADD'L SURGERY TO REMOVE AND REPLACE THE DEVICE WHICH TO DATE IS KNOWN TO HAVE OCCURRED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SYNCHROMED II MEDTRONIC SYNCHROMED II LKK MEDTRONIC, INC. NGP351036H

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization