BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3926173 · Received June 17, 2014

    Report

    Report Number
    1627487-2014-25453
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    November 26, 2013
    Report Date
    May 30, 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
    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

    THE PT HAS A CERVICAL AND THORACIC SCS SYSTEM. THE EVENT IS RELATED TO THE PT'S THORACIC SYSTEM. IT WAS REPORTED THE PT'S PROGRAMMER AND CHARGER ARE UNABLE TO COMMUNICATE WITH THE IPG. ADDITIONALLY, THE PT STATED SHE STOPPED CHARGING THE SYSTEM DUE TO NOT RECEIVING STIMULATION. LOSS OF STIMULATION REPORTED UNDER MFR. REPORT# 627487-2013-20618. AS A RESULT, THE PT'S IPG IS INOPERABLE DUE TO LACK OF RECHARGE. IN TURN, THE PT WILL UNDERGO SURGICAL INTERVENTION TO EXPLANT THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353847 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 4049356

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other IMPLANT DATE:| IMPLANT DATE:| SCS LEADS: MODEL 3186 (X2)| SCS ANCHORS: MODEL 1192 (X2)