BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2780353 · Received October 5, 2012

    Report

    Report Number
    1627487-2012-01810
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    September 9, 2009
    Report Date
    September 14, 2012
    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

    CORRECTION NUMBERS: 1627487-05242011-002-R, 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY 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 3. REFERENCE MFR REPORT# 1627487-2012-1811. REFERENCE MFR REPORT# 1627487-2012-1812. IT WAS REPORTED THE PT EXPERIENCED A HEATING SENSATION AT HER IPG SITE WHILE CHARGING. SHE ONLY CHARGED HER IPG ONCE AFTER IMPLANT. IT WAS ALSO REPORTED SHE WAS NOT RECEIVING EFFECTIVE STIMULATION ON HER LEFT SIDE. THE PT HAS NOT USED OR CHARGER HER SCS SYSTEM SINCE 2009 WHEN SHE FELT THE HEATING WHILE CHARGING. FOLLOW UP INFO IDENTIFIED HER IPG IS SHALLOW CAUSING PAIN AT HER IPG SITE. SHE IS CONSIDERING REVISION SURGERY. ON (B)(6) 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
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2834055

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention