BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3926161 · Received June 2, 2014

    Report

    Report Number
    1627487-2014-02390
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    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 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 COMPLAINING OF PAIN AT HER SCS IPG SITE. THE PT CONSULTED WITH HER PHYSICIAN WHO SUGGESTED A REVISION OR EXPLANT OF THE PT'S SCS SYSTEM. SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320923 EON MINI SCS IPG GZB ST JUDE MEDICAL - NEUROMODULATION 3788 3769617

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (X2)| IMPLANT DATE:| SCS LEAD: MODEL 3186 (X2)| IMPLANT DATE:| SCS EXTENSION: MODEL 3383 (X2)