BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4142935 · Received September 23, 2014

    Report

    Report Number
    1627487-2014-08305
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 4, 2013
    Report Date
    September 4, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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 PT IS EXPERIENCING SWELLING AND DISCOMFORT DESCRIBED AS A WARMING OF THE AREA NEAR THE IPG POCKET. THE PT REPORTEDLY CONTINUES TO HAVE EFFECTIVE STIMULATION. SURGICAL INTERVENTION IS PLANNED FOR A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590904 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3410804

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other SCS LEAD, MODEL 3214| IMPLANT DATE