BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3123569 · Received May 17, 2013

    Report

    Report Number
    1627487-2013-15656
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C 1
    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: 1627487-07262012-002-R, 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES AND A FIELD 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 #1627487-2013-12657. IT WAS REPORTED THE PT EXPERIENCES HEATING AT THE IPG SITE WHILE CHARGING AND WHEN STIMULATION IS TURNED ON HIGH. A REPLACEMENT LE CHARGING SYSTEM WAS SENT TO THE PT. F/U IDENTIFIED THE PT'S ISSUE REGARDING HEATING AT THE IPG SITE WHILE CHARGING WAS RESOLVED WITH THE USE OF THE REPLACEMENT CHARGING SYS. ON (B)(4) 2012 ST. JUDE MEDICAL, NEUROMODULATION DIV, 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
    219761 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2794334

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention IMPLANT:| SCS EXTENSION: MODEL 3383 (2)| IMPLANT:| SCS LEAD: MODEL 3219