BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3192035 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-08236
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 WAS EXPERIENCING BURNING SENSATION WHEN THE STIMULATION WAS ON. FOLLOW-UP INFORMATION RECEIVED THE PATIENT MAY WANT TO HAVE THE DEVICE REMOVED AND HAD BEEN SCHEDULED FOR A CONSULTATION WITH THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281545 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3757251

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other IMPLANT DATE:| SCS LEAD, MODEL 3244| IMPLANT DATE:| SCS LEAD, MODEL 3163 (2)| IMPLANT DATE:| SCS EXTENSION, MODEL 3342