BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3022390 · Received March 22, 2013

    Report

    Report Number
    1627487-2013-03405
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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

    THE PATIENT REPORTED EXPERIENCING HER STIMULATION TURNING OFF BY ITSELF. FOLLOW-UP IDENTIFIED A SJM REPRESENTATIVE WAS UNABLE TO CONFIRM THE ISSUE. THE ISSUE IS BEING MONITORED FOR OCCURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120285 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3617220

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention SCS LEAD: MODEL 3219| IMPLANT: