BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44

    MDR report key: 2980006 · Received February 22, 2013

    Report

    Report Number
    1627487-2013-03255
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    September 27, 2012
    Report Date
    January 28, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-03245. THE PATIENT REPORTED HE IS EXPERIENCING HEATING/BURNING AT HIS SCS IPG POCKET SIT WHILE USING SYSTEM STIMULATION. THE PATIENT ALSO REPORTED HIS SCS IPG POCKET SITE IS "SENSITIVE TO THE TOUCH". FOLLOW-UP IDENTIFIED THE PATIENT HAS ALSO BEEN EXPERIENCING PAIN AT HIS SCS IPG POCKET SITE SINCE IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77696 LAMITRODE 44 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3262 3410896

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention