BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2843451 · Received November 19, 2012

    Report

    Report Number
    1627487-2012-11685
    Event Type
    Injury
    Date Received
    November 19, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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

    DEVICE 1 OF 3. REFERENCE MFR REPORT: 1627487-2012-11686 AND 1627487-2012-11687. IT WAS REPORTED THE PT WAS UNABLE TO CHARGE THE IPG. THE SJM REP MET WITH THE PT AND AN X-RAY WAS TAKEN WHICH REVEALED THE IPG WAS NOT FLAT, BUT WAS FLIPPED ON ITS SIDE. IT WAS ALSO NOTED IN THE X-RAY ONE LEAD HAD MIGRATED. FOLLOW UP IDENTIFIED THE IPG WAS SUTURED DOWN ON (B)(6) 2012, AND THE LEADS WERE REPOSITIONED DURING THE SAME PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL NEUROMODULATION 3788 3762384

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1192