BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3141093 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-03699
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    December 2, 2012
    Report Date
    May 2, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL: 1627487-07262012-002-R, 1627487-07262012-001-C. 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. REF MFR REPORT: 1627487-2013-03700. THE PT REPORTED EXPERIENCING WARMING AT HER SCS IPG POCKET SITE WHILE CHARGING. SUBSEQUENTLY, A REPLACEMENT CHARGING SYSTEM (LOW ENERGY) WAS SENT TO THE PT. THE PT ALSO REPORTED DISCOMFORT AT THE POCKET SITE REGARDLESS OF STIMULATION (REF MFR REPORTS: 1627487-2013-13737 AND 1627487-2013-13738). F/U IDENTIFIED THE POCKET HEATING ISSUE RESOLVED WITH THE REPLACEMENT CHARGING SYSTEM. ON 08/01/2012 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 ARE EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230645 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2893991

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)| SCS ANCHOR: MODEL 1194 (2)