BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3110795 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-02627
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 16, 2012
    Report Date
    April 16, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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

    RECALL NUMBERS: 1627487-05242011-002-R, 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION AND FIELD ADVISORIES. SJM HAS LIMITED INFORMATION 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: 1627487-2013-02628. IT WAS REPORTED THE PT HAS EXPERIENCED UNCOMFORTABLE POCKET HEATING WHILE CHARGING FOR APPROX ONE YR. SHE STATED THE ISSUE HAD MADE HER IPG SITE SENSITIVE FOR SEVERAL DAYS. A NEW LE CHARGING SYSTEM WAS SENT TO THE PT. SHE ALSO REPORTED SHE HAS INTERMITTENT COMMUNICATION ISSUES WHILE USING HER PROGRAMMER. HER IPG ALLEGEDLY IS LOCATED IN HER ABDOMEN AND MOVES AROUND. SHE STATED SHE IS ABLE TO RE-ESTABLISH COMMUNICATION BY REPOSITIONING THE IPG AND PROGRAMMER WAND. ON (B)(4) 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
    204722 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2805908

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention SCS LEAD: MODEL 3186 (2)| IMPLANT DATE: