BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3850534 · Received May 30, 2014

    Report

    Report Number
    1627487-2014-03374
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 6, 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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S PNS SYSTEM (OFF-LABEL) WAS EXPLANTED DUE TO DISCOMFORT AT THE SCS POCKET SITE IN ADDITION TO THE SCS IPG PROTRUDING AND BEING CAUGHT ON OBJECTS. THE PT NOW HAS A PAIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319718 EON MINI SCS IPG GZB ST JUDE MEDICAL - NEUROMODULATION 3788 3798698

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3186| SCS ANCHOR: MODEL 1194| SCS LEAD: MODEL 3186