BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3890919 · Received June 4, 2014

    Report

    Report Number
    1627487-2014-02397
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 UNDERWENT WEIGHT LOSS SURGERY AND HAS LOST A SIGNIFICANT AMOUNT OF WEIGHT. CONSEQUENTLY, THE PT EXPERIENCED DIFFICULTY COMMUNICATING WITH HER SCS IPG AND THE CHARGER. THE PT STATED SHE LOST STIMULATION THERAPY SOMETIME IN (B)(6) 2013, BECAUSE OF NOT BEING ABLE TO RECHARGE HER SCS SYSTEM, AND DUE TO COMPLICATIONS FROM THE ABDOMINAL SURGERY. SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325676 EON MINI SCS IPG GZB ST JUDE MEDICAL - NEUROMODULATION 3788 3802532

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other SCS LEAD: MODEL 3186| SCS EXTENSION: MODEL 3383