BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SYNCHROMED 2

    MDR report key: 1990032 · Received February 9, 2011

    Report

    Report Number
    MW5019394
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    August 9, 2010
    Report Date
    February 9, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BEGINNING IN (B)(6) 2010, I BEGAN HAVING WITHDRAWAL SYMPTOMS FROM MORPHINE WHILE USING MEDTRONIC'S SYNCHROMED 2 PAIN PUMP INSTALLED IN (B)(6) 2006. THE SYMPTOMS HAVE RESULTED IN HOSPITALIZATION DUE TO SUICIDAL INCLINATION IN (B)(6) 2010. MY PHYSICIAN HAS DISCONTINUED USING THE PUMP ON (B)(6) 2011 AND REPLACEMENT IS BEING SCHEDULED. THE PUMP BATTERY SHOWS 28 MONTHS OF LIFE LEFT. DATES OF USE: (B)(6) 2006 - (B)(6) 2011. REASON FOR USE: CHRONIC PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SYNCHROMED 2 INFUSION PUMP LKK MEDTRONIC 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L