BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3182141 · Received June 14, 2013

    Report

    Report Number
    1627487-2013-06474
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    February 1, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAS BEEN EXPERIENCING A BURNING AND ACHING AT HIS IPG SITE WHETHER THE STIMULATION IS ON OR OFF. THE PT ALSO STATED HE STOPPED USING THE SYSTEM ABOUT A MONTH AGO BECAUSE OF THE ISSUE. THE PT IS PENDING A FOLLOW-UP WITH HIS PHYSICIAN TO DISCUSS WHETHER TO RELOCATE HIS IPG OR RECEIVED LOCAL INJECTIONS TO HELP WITH HIS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271639 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3721484

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other SCS LEAD: MODEL 3286| IMPLANTED:| SCS ANCHOR: MODEL 1192| IMPLANTED: