BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2926070 · Received January 17, 2013

    Report

    Report Number
    1627487-2013-02100
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    IT WAS REPORTED THE PATIENT FELT A BURNING SENSATION AT THE IPG SITE WHEN STIMULATION WAS ON OR OFF. THE PHYSICIAN EXAMINED THE SITE AND FOUND NO ISSUES. FOLLOW-UP IDENTIFIED THE HEATING HAD SUBSIDED AND THE PHYSICIAN FELT THE ISSUE MAY HAVE BEEN DUE TO A SEROMA. IT WAS REPORTED THE PATIENT HAD SLIGHT SWELLING AT THE SITE AND WILL NOTIFY HER PHYSICIAN IF IT WORSENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25388 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3869039

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention IMPLANT DATE:| SCS LEAD, MODEL 3219