BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3223213 · Received July 10, 2013

    Report

    Report Number
    1627487-2013-06597
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    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
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION NUMBER: 1627487-07262012-001-C, 1627487-12192011-003-R AND 1627487-05242011-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION AND FIELD ADVISORIES. 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 3. REFERENCE MFR REPORT: 1627487-2013-06598. REFERENCE MFR REPORT: 1627487-2013-06599. THE PATIENT HAS TWO SYSTEMS, ALL POSSIBLE DEVICES ARE BEING REPORTED. IT WAS REPORTED THE PATIENT EXPERIENCES UNCOMFORTABLE POCKET HEATING WHILE CHARGING. THE PATIENT ALSO STATED IT TAKES TEN HOURS TO CHARGE HER CHARGER, AND SHE BELIEVES HER CHARGER IS MALFUNCTIONING. A NEW CHARGING SYSTEM WAS SENT TO THE PATIENT TO ADDRESS THE ISSUES. ON 08/01/2012 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
    317886 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2757137

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other SCS LEAD: MODEL 3228| IMPLANT DATE:| SCS EXTENSION: MODEL 3383 (X2)| IMPLANT DATE:| SCS LEAD: MODEL 3214| IMPLANT DATE: