BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3192258 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-02863
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    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 WENT TO THE EMERGENCY ROOM BECAUSE SHE COULD NOT TURN HER STIMULATION OFF. THE SJM REPRESENTATIVE MET WITH THE PATIENT, AND HE ALLEGEDLY WAS ABLE TO COMMUNICATE WITH ER IPG WITHOUT DIFFICULTY AND TURN STIMULATION OFF. IT WAS REPORTED THE PATIENT WAS ON MEDICINE AND UNABLE TO CONFIRM HER REASON FOR COMING TO THE EMERGENCY ROOM. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281775 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3886850

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR IMPLANT DATE:| SCS LEAD: MODEL 3228