BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3182176 · Received June 14, 2013

    Report

    Report Number
    1627487-2013-01691
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT IS EXPERIENCING A BURNING SENSATION AT HER IPG SITE WHEN SHE TURNS STIMULATION ON. AN SJM REP MET WITH THE PATIENT AND LEAD DIAGNOSTICS SHOWED ALL IMPEDANCES WERE LOW. THE PATIENT IS RECEIVING EFFECTIVE STIMULATION. X-RAYS MAY BE DONE TO ASSESS THE INTEGRITY OF THE IPG HEADER AND LEAD CONNECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270763 EON MINI SCS IPG LGW ST. JUDE MEDICAL -NEUROMODULATION 3788 4024874

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other SCS LEAD: MODEL 3186 (2)| IMPLANT DATE: