BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2993948 · Received March 1, 2013

    Report

    Report Number
    1627487-2013-02317
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    August 7, 2012
    Report Date
    February 7, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATON
    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 PT HAS EXPERIENCED AN ELECTRICAL/BURNING SENSATION AT HER IPG SITE FOR APPROXIMATELY 6 MONTHS. THE PT ALLEGEDLY WAS UNSURE WHETHER THIS OCCURS WHEN STIMULATION IS ON OR OFF. IT WAS REPORTED THE SJM REP WILL MEET WITH THE PT TO INVESTIGATE THE ISSUE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89252 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATON 3788 3625636

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)