BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3890601 · Received June 3, 2014

    Report

    Report Number
    1627487-2014-21352
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 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 GAINED WEIGHT AND SHE WAS UNABLE TO ESTABLISH TELEMETRY WITH THE IPG. THE PT HAD NOT USED/CHARGED THE IPG FOR APPROXIMATELY THREE MONTHS. THE SJM REPRESENTATIVE CONFIRMED LOSS OF COMMUNICATION USING MULTIPLE EXTERNAL DEVICES. THE PT WILL UNDERGO SURGICAL INTERVENTION TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324324 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3535799

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other IMPLANT DATE:| SCS LEAD: MODEL 3186(2)