BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 4371894 · Received December 30, 2014

    Report

    Report Number
    1627487-2014-03798
    Event Type
    Injury
    Date Received
    December 30, 2014
    Date of Event
    December 9, 2014
    Report Date
    February 11, 2015
    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
    OTHER

    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.

    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.

    Additional Manufacturer Narrative · 1

    RESULTS: THE COMPLAINT OF ¿DISCOMFORT¿ WAS CONFIRMED. AS RECEIVED, THE IPG WAS RESPONSIVE AND COMMUNICATED WITH LAB UTILITIES. A VISUAL INSPECTION OF THE DEVICE FOUND A CORED SEPTUM IN THE LOWER CHAMBER. IT WAS NOTED ELECTRODE 1 WAS PROGRAMMED, WHICH WAS UNDER THE CORED SEPTUM. THE CORED SEPTUM COULD RESULT IN FLUID INTRUSION INTO THE HEADER ASSEMBLY, WHICH CAN RESULT IN CHANGES TO THE SYSTEM IMPEDANCES AND STIMULATION. DESPITE THE CORED SEPTUM, THE DEVICE PASSED ALL MECHANICAL AND ELECTRICAL TESTING DURING ANALYSIS. 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.

    Additional Manufacturer Narrative · 1

    UDI(DI): (B)(4). 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 WAS EXPERIENCING A "JOLTING SENSATION" REGARDLESS OF STIMULATION WHICH BEGAN AT THE LEAD SITE AND TRAVELED DOWN TO THE SCS IPG POCKET SITE. AS A RESULT, THE SCS IPG WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL.

    Description of Event or Problem · 1

    FURTHER INVESTIGATION IDENTIFIED THE ISSUE RESOLVED WITH THE SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857015 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3717482

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other MODEL 3228, SCS LEAD