BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2792197 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-03513
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    August 15, 2011
    Report Date
    September 18, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-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 NUMBERS: 1627487-07262012-002-R, 1627487-07262012-001-C. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. THIS IPG SERIAL NUMBER WAS INCLUDED IN 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: 1627487-2012-03514. IT WAS REPORTED THE PATIENT IS NOT USING HER SCS SYSTEM DUE TO EXPERIENCING UNCOMFORTABLE HEATING AND REDNESS (AREA UNDER THE ANTENNA) AT HER SCS IPG POCKET SITE WHILE CHARGING HER SCS SYSTEM. IT WAS ALSO REPORTED THE PATIENT'S SCS IPG HAS BECOME MORE SUPERFICIAL SINCE IMPLANTATION AND IS AT A 45 DEGREE ANGLE DUE TO PROBLEMS DURING THE PERMANENT PROCEDURE PER THE PATIENT. ADDITIONALLY, THE PADDLE OF THE ANTENNA BECOMES HOT DURING CHARGING. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PATIENT. THE PATIENT IS WORKING WITH THE PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION. 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 IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2819330

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE:| SCS LEAD: MODEL 3219