BEUDAMED
    FDA Adverse Event Death Summary report: N

    EON MINI

    MDR report key: 2875071 · Received December 13, 2012

    Report

    Report Number
    1627487-2012-02825
    Event Type
    Death
    Date Received
    December 13, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 30, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 PT PASSED AWAY ABOUT A WEEK AGO. THE CAUSE OF DEATH IS CURRENTLY UNK. FOLLOW-UP IN PROGRESS TO OBTAIN ADDITIONAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 176158

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death SCS LEAD: MODEL 3186| IMPLANTED: