BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4091828 · Received August 28, 2014

    Report

    Report Number
    1627487-2014-03558
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    September 13, 2010
    Report Date
    August 8, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL: 1627487-07262012-002-R, 1627487-07262012-001-C, 0167487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES AND A FIELD CORRECTION. SJM HAS LIMITED INFO 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

    DEVICE 1 OF 3. REFERENCE MFR REPORT# : 1627487-2014-03559, 1627487-2014-03560. IT WAS REPORTED THE PATIENT ALLEGES THE IPG TURNING ITSELF ON AND OFF, "SHOCKING", AND HEATING AT HIS SCS IPG POCKET SITE WHILE CHARGING. SURGICAL INTERVENTION MAY BE PENDING. ADDITIONAL INFO IS NEEDED TO CLARIFY THE NATURE OF THE PATIENT'S ISSUES. SJM WAS MADE AWARE OF THE ISSUES ON (B)(6) 2014, AND THE PATIENT'S SCS SYSTEM WAS NOT EVALUATED BY AN SJM REP TO VERIFY AND/OR TROUBLESHOOT ANY OF THE REPORTED ISSUES. ON 08/01/2012 ST. JUDE MEDICAL, NEUROMODULATION DIV, SENT FIELD ACTION LETTERS TO PATIENTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526639 EON MINI SCS IPG, GZB GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2891072

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other