BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3141173 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-12725
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    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'S IPG GETS HOT AND THE SITE IS SWOLLEN. THE PATIENT STATES THE IPG SITE IS HOT WITH SIMULATION ON AND OFF. THE PATIENT PLANS SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230583 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3790458

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention IMPLANT:| SCS LEAD: MODEL 3219