BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3201833 · Received June 26, 2013

    Report

    Report Number
    1627487-2013-15863
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 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'S IPG WAS EXPLANTED BECAUSE THE PATIENT FELT IT WAS SWOLLEN AND UNCOMFORTABLE. FOLLOW-UP INDICATED THE PATIENT STATED HE FELT HIS BODY WAS "REJECTING" THE IPG AND HE EXPERIENCED INTERMITTENT SWELLING AT THE IPG LOCATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290622 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3593625

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other IMPLANT:| SCS ANCHOR: MODEL 1192 (2)| SCS LEAD: MODEL 3228| IMPLANT: