BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3960979 · Received July 22, 2014

    Report

    Report Number
    1627487-2014-20064
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    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 EXPERIENCED DISCOMFORT AT THE SCS IPG POCKET SITE DUE TO MIGRATION AS A RESULT OF LOSING WEIGHT. AS A RESULT, THE SCS SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429184 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3779819

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)