BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2741111 · Received September 10, 2012

    Report

    Report Number
    1627487-2012-02273
    Event Type
    Injury
    Date Received
    September 10, 2012
    Date of Event
    July 31, 2012
    Report Date
    August 21, 2012
    Manufacturer
    ST. JUDE MEDICAL ¿ NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY AND 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: 1627487-2012-02274. IT WAS REPORTED THE PT ALWAYS FEELS HEATING AT THE IPG SITE WHILE CHARGING. SHE REPORTED ABOUT THREE WEEKS AGO SHE RECEIVED A SMALL BURN ON HER SKIN AND APPLIED LOTION TO IT. SHE STATED SHE WAS NOT AWARE OF THE BURN DURING CHARGING BUT OBSERVED A SMALL BROWN SPOT ON HER SKIN AFTERWARDS. SHE STATED SHE CHARGED FOR 1.5 - 2 HOURS THAT TIME BUT NOW SHE CHARGES FOR ONLY 45 MINUTES AT A TIME. THE SJM REP ADVISED THE PT OF CHARGING PRECAUTIONS AND THE PT STATED SHE IS USING THE CHARGING BELT AND ANTENNA POUCH. NO FURTHER INFO IS AVAILABLE AT THIS TIME. 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 3504452

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention IMPLANTED:| SCS LEAD: MODEL 3228