BEUDAMED
    FDA Adverse Event Death Summary report: N

    EON MINI

    MDR report key: 3060072 · Received April 11, 2013

    Report

    Report Number
    1627487-2013-02482
    Event Type
    Death
    Date Received
    April 11, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    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 DIED ON (B)(6) 2013. IT WAS REPORTED THE PT HAD ONGOING MEDICAL PROBLEMS THAT KEPT HIM IN THE HOSPITAL. FURTHER INVESTIGATION IDENTIFIED AN OBITUARY STATED THE PT DIED AT A SKILLED NURSING FACILITY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156573 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3504711

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death IMPLANT DATE:| SCS ANCHOR, MODEL 1192| SCS LEAD, MODEL 3228| IMPLANT DATE: