BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2892915 · Received December 28, 2012

    Report

    Report Number
    1627487-2012-02921
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    ST. JUDE MEDICLA - 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION. SJM HAS LIMITED INFORMATION 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: 1627487-2012-02922. IT WAS REPORTED, THE PT EXPERIENCED IPG POCKET HEATING WHILE CHARGING. THE PT REPORTED, SHE STOPPED USING HER SCS SYSTEM WHEN SHE RECEIVED A LETTER FROM THE MANUFACTURER. SHE STATED, SHE WANTED HER SYSTEM REMOVED AND WAS NOT RECEPTIVE TO MEETING WITH AN SJM REPRESENTATIVE. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PT BUT ALLEGEDLY THERE WAS NO IMPROVEMENT. NO FURTHER INFORMATION 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 MEDICLA - NEUROMODULATION 3788 3549342

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)| SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE: