BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4162948 · Received October 8, 2014

    Report

    Report Number
    1627487-2014-20300
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 17, 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 INFORMATION 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

    IT WAS REPORTED THE PT WAS UNABLE TO ESTABLISH COMMUNICATION BETWEEN HER IPG AND EXTERNAL DEVICES. SJM REPRESENTATIVE CONFIRMED THE ISSUE BY USING MULTIPLE EXTERNAL DEVICES. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631557 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3844402

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL 1192(2)| IMPLANT DATE:| SCS LEAD: MODEL 3186, 3183