BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3821063 · Received May 9, 2014

    Report

    Report Number
    1627487-2014-03326
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 17, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    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

    IT WAS REPORTED, THE PT IS UNABLE TO ESTABLISH COMMUNICATION BETWEEN HER SCS IPG AND CHARGING SYSTEM AS WELL AS HER PT PROGRAMMER DISPLAYS AN 2501 COMM ERROR MESSAGE UPON ATTEMPTING TO COMMUNICATE WITH THE SCS IPG. AS A RESULT, THE PT IS WITHOUT STIMULATION. FOLLOW-UP IDENTIFIED X-RAYS REVEALED THE SCS IPG HAS FLIPPED. DUE TO UNRELATED HEALTH ISSUES, THERE IS A POSSIBILITY THE SCS SYSTEM WILL BE EXPLANTED IN ORDER FOR THE PT TO UNDERGO AN MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282176 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3632836

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other IMPLANTED:| IMPLANTED:| SCS ANCHOR: MODEL 1194| IMPLANTED:| SCS LEAD: MODEL 3186| SCS LEAD: MODEL 3186