BEUDAMED
    FDA Adverse Event Death Summary report: N

    EON MINI

    MDR report key: 3202084 · Received June 26, 2013

    Report

    Report Number
    1627487-2013-15867
    Event Type
    Death
    Date Received
    June 26, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION NUMBER: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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 HAD PASSED AWAY. THE CAUSE OF DEATH WAS NOT PROVIDED. F/U INFO INDICATED ATTEMPTING TO CONTACT THE PT'S PHYSICIAN TO DETERMINE THE CAUSE OF DEATH WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289505 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2834054

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death IMPLANT DATE:| SCS LEAD: MODEL 3214