BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4093665 · Received September 4, 2014

    Report

    Report Number
    1627487-2014-08232
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 7, 2014
    Report Date
    November 24, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FILED CORRECTION. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2014-08233. INFO RECEIVED IDENTIFIED THE PT ALLEGED TO HAVE EXPERIENCED "OVERHEATING LEADING TO BURNING SENSATIONS" AS WELL AS INCREASED RECHARGE TIME. THE PT IS REPORTEDLY NO LONGER USING HIS SCS SYSTEM. ADD'L INFO IS NEEDED TO CLARIFY THE NATURE OF THE PT'S HEATING ISSUES. SJM WAS MADE AWARE OF THE ISSUES ON (B)(6) 2014, AND THE PT'S SCS SYSTEM WAS NOT EVALUATED BY AN SJM REPRESENTATIVE TO VERIFY AND/OR TROUBLESHOOT ANY OF THE REPORTED ISSUES. ON 08/01/2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PTS. 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
    541540 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3590615

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other SCS LEAD, MODEL 3288| SCS EXTENSION, MODEL 3386 (X2)| IMPLANT DATE:| IMPLANT DATE: