BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2792016 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-12272
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    July 19, 2012
    Report Date
    September 19, 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
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER INCLUDED IN A FIELD ADVISORY AND A FIELD CORRECTION. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT #1627487-2012-12273. THE PATIENT REPORTED UNCOMFORTABLE HEATING, SORENESS AND REDNESS AT THE IPG SITE WHEN CHARGING. THE PATIENT HAS TURNED THE STIMULATION OFF DUE TO HER CONCERNS. AN SJM REPRESENTATIVE SUGGESTED MEETING WITH THE PHYSICIAN AND SJM LOCAL REPRESENTATIVE. THE NEXT COURSE OF ACTION WAS UNDETERMINED. ON (B)(6) 2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PATIENTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. 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 LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3365377

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention