BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3110909 · Received May 8, 2013

    Report

    Report Number
    1627487-2013-03610
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    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
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN 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 2. REFERENCE MFR REPORT: 1627487-2013-03611. THE PATIENT REPORTED SHE EXPERIENCES HEATING AT HER SCS IPG POCKET SITE WHILE CHARGING. THE PATIENT ALSO REPORTED THE POCKET SITE BECAME RED AND PAINFUL. THE HEATING RESOLVES AWHILE AFTER CHARGING. A REPLACEMENT CHARGING SYSTEM (LOW ENERGY) HAS BEEN SENT TO THE PATIENT. NO ADD¿L INFO IS AVAILABLE AT THIS TIME. ON (B)(4) 2012 ST. JUDE MEDICAL, NEUROMODULATION DIV, 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
    200159 EON MINI SCS IPG LGW ST. JUDE MEDICAL- NEUROMODULATION 3788 3792918

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SCS LEAD: MODEL 3228| IMPLANT DATE: