BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2921771 · Received January 14, 2013

    Report

    Report Number
    1627487-2013-10016
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 26, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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 ((B)(6)) FELT A SUDDEN INCREASE IN STIMULATION FOLLOWED BY A COMPLETE LOSS OF STIMULATION. IN ADDITION, THE PATIENT REPORTED, HE COULD NO LONGER ESTABLISH COMMUNICATION BETWEEN THE SCS IPG AND THE EXTERNAL DEVICES (PATIENT PROGRAMMER AND CHARGING SYSTEM). A DIFFERENT PATIENT PROGRAMMER AND CHARGING SYSTEM WERE TRIED TO NO AVAIL. THE IPG WAS EXPLANTED AND REPLACED WHICH RESOLVED THE REPORTED ISSUE. EFFECTIVE STIMULATION WAS RESTORED POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19945 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3422914

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention