BEUDAMED
    FDA Adverse Event Death Summary report: N

    EON

    MDR report key: 3861596 · Received May 23, 2014

    Report

    Report Number
    1627487-2014-12370
    Event Type
    Death
    Date Received
    May 23, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS: THE IPG SUCCESSFULLY COMMUNICATED WITH A LAB PT PROGRAMMER. MICROSCOPIC INSPECTION OF THE RETURNED EON (3716) REVEALED TOOLING MARKS ON THE HEADER FROM THE EXPLANT PROCEDURE. SEPTUMS WERE INTACT AND CLEAR. THE HEADER IS CLEAR AND THERE IS NO INDICATION OF FLUID INTRUSION. THE IPG WAS TESTED TO MFG SPECIFICATIONS USING THE AUTOTESTER AND PASSED ALL TESTS. THE DEVICE WAS RETURNED IN GOOD CONDITION AND PASSED ALL FUNCTIONAL TESTING. THERE IS NO ALLEGED FAILURE OF THE DEVICE TO MEET SPECIFICATION AND IT IS ASSUMED THE DEVICE WAS RETURNED FOR DISPOSAL. 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 PT'S SCS IPG WAS RETURNED TO ST. JUDE MEDICAL FROM A MORTICIAN'S OFFICE. AN INTERNET OBITUARY SEARCH WAS PERFORMED AND NOTHING RELATED TO THE PT'S DEATH WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309137 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 65925

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death