BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3141154 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-05728
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    January 29, 2013
    Report Date
    April 27, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. RESULTS: AS RECEIVED, THE IPG WAS IN NORMAL USAGE CONDITION. THE TOP SEPTUM SHOWED FLUID INTRUSION AND ELECTROCAUTERY MARKS WERE FOUND ON THE CAN. THE IPG WAS TESTED TO MANUFACTURING SPECIFICATIONS AND PASSED ALL TESTS. 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 2 OF 2. REFERENCE MFR. REPORT NUMBER: 1627487-2012-06266.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230646 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3148361

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention SCS ANCHORS: MODEL 1194 (2)| IMPLANT: