BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MIN

    MDR report key: 3223239 · Received July 10, 2013

    Report

    Report Number
    1627487-2013-06594
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 INFORMATION 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 PATIENT IS EXPERIENCING AN INTERMITTENT STINGING AND PAINFUL SENSATION AT HIS IPG SITE. AN SJM REPRESENTATIVE CONTACTED THE PATIENT AND THE PATIENT AGREED TO MONITOR THE ISSUE FOR THE TIME BEING. FOLLOW-UP IDENTIFIED THE PATIENT REPORTED THE ISSUE HAS NOT RE-OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314905 EON MIN SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3941750

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (X3)| SCS LEAD: MODEL 3169 (X2)| IMPLANT DATE:| SCS LEAD: MODEL 3189| IMPLANT DATE:| SCS EXTENSION: MODEL 3341 (X2)| IMPLANT DATE: