BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3861958 · Received May 7, 2014

    Report

    Report Number
    1627487-2014-26392
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 17, 2014
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    GZB
    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 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 IS EXPERIENCING POCKET HEATING WITH STIMULATION ON. PT TURNED OFF THE SYSTEM AND WENT TO BED. WHEN HE WOKE UP THE IPG SITE WAS NO LONGER HOT. THE PT IS CURRENTLY REFUSING TO USE HIS SCS SYSTEM. F/U INFO IDENTIFIED THE PT EXPERIENCES GROIN PAIN AND THE SURROUNDING IPG POCKET AREA IS EXTREMELY HOT WHEN HE TURNS THE SYSTEM ON. SURGICAL INTERVENTION IS PENDING TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274505 EON MINI SCS IPG GZB ADVANCED NEUROMODULATION SYSTEMS 3788 4350112

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other SCS LEAD: MODEL 3219| IMPLANT DATE: