BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3820901 · Received May 13, 2014

    Report

    Report Number
    1627487-2014-12353
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 22, 2014
    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 EXPERIENCES BURNING AND DISCOMFORT AT THE IPG SITE. SURGICAL INTERVENTION IS PLANNED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287511 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 4252499

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other SCS IPG: MODEL 3228| IMPLANT DATE: