BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED 2

    MDR report key: 1419093 · Received July 17, 2009

    Report

    Report Number
    1419093
    Event Type
    Malfunction
    Date Received
    July 17, 2009
    Date of Event
    February 5, 2009
    Report Date
    July 17, 2009
    Manufacturer
    MEDTRONIC
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAILURE OF IMPLANTED MEDTRONIC PUMP INTENDED FOR CHRONIC PAIN MANAGEMENT. THE PT FINALLY PRESENTED TO THE ED AFTER 3 DAYS OF HEARING AN ALARM; HE REPORTED 2 WEEKS OF INCREASING PAIN (PUMP CONTAINS HYDROMORPHONE). ONCE IN THE ED, HE WAS TREATED THROUGH OTHER MEANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED 2 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC SYNCHROMED 2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR