BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3950307 · Received June 19, 2014

    Report

    Report Number
    1627487-2014-15473
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 28, 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

    THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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

    DEVICE 1 OF 3. REFER TO MFR REPORTS 1627487-2014-15474, 1627487-2014-15475. THE PATIENT HAD 2 LEADS (FROM THE SAME LOT) AS WELL AS 2 ANCHORS (FROM THE SAME LOT) IMPLANTED AS PART OF HER SCS SYSTEM. IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL DUE TO EXPERIENCING TENDERNESS AND REDNESS AT HER IPG, LEAD AND ANCHOR INCISION SITES. THE PHYSICIAN SUSPECTED AN INFECTION AND OPENED THE INCISION SITES TO CLEANSE THEM, BUT UPON OPENING, ELECTED TO EXPLANT THE PATIENT'S SCS SYSTEM. THE PHYSICIAN INDICATED THAT THE PATIENT'S IMMUNE SYSTEM MAY HAVE BEEN COMPROMISED DUE TO MEDICATION SHE TAKES FOR RHEUMATOID ARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360497 EON MINI SCS IPG GZB ST JUDE MEDICAL - NEUROMODULATION 3788 4373072

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization