BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2893128 · Received December 28, 2012

    Report

    Report Number
    1627487-2012-13283
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    November 9, 2012
    Report Date
    December 3, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R,
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: 1627487-07262012-001-C. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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: 1627487-2012-13284. IT WAS REPORTED, THE PT EXPERIENCED EXTREME HEATING WHILE CHARGING AT HIS IPG SITE WHICH CREATED A SMALL BLISTER ON THE SKIN. THE PT FEELS THE RELIEF OF THE SYSTEM AND ONLY FEELS THE HEATING WHILE CHARGING. THE PT TO FOLLOW-UP WITH THE PHYSICIAN TO ADDRESS THE ISSUE. 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
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3190350

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL: 3214