BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2885046 · Received December 18, 2012

    Report

    Report Number
    1627487-2012-06968
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    LGW
    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 INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT WENT TO THE EMERGENCY ROOM DUE TO THE IPG SITE OPENING UP AND THE IPG BEING EXPOSED. THE PHYSICIAN DECIDED TO REMOVE THE STAPLES AND SUTURE THE POCKET SITE. CULTURES WERE TAKEN AND NO SIGNS OF INFECTION WERE FOUND. THE PT WAS GIVEN ANTIBIOTICS AS A PRECAUTION. ON (B)(6) 2012, THE PATIENT MET WITH HER DOCTOR DUE TO THE WOUND OPENING AGAIN. THE DOCTOR IRRIGATED THE WOUND AND CLOSED IT. AGAIN, NO SIGNS OF INFECTION WERE FOUND. THE PT WILL FOLLOW-UP WITH HER DOCTOR ON A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL NEUROMODULATION 3788 3834301

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R IMPLANT:| SCS LEADS: MODEL 3186(2)| IMPLANT:| SCS ANCHORS: MODEL 1194(2)