BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2980048 · Received February 22, 2013

    Report

    Report Number
    1627487-2013-13346
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    July 31, 2011
    Report Date
    January 31, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-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/REMOVAL NUMBERS: 1627487-12192011-003-R & 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. SJM HAS LIMITED INFO 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. REF MFR REPORT: 1627487-2013-13347. IT WAS REPORTED THE PT WAS FEELING A BURNING SENSATION AROUND HER IPG SITE. THE PT STATED SHE HAS NOT CHARGED HER IPG FOR APPROX THE LAST 18 MONTHS, HOWEVER, SHE STILL FEELS THE BURNING SENSATION. IT WAS ALSO REPORTED THE PT WAS NO LONGER ABLE TO COMMUNICATE WITH HER IPG USING EITHER THE PROGRAMMER OR CHARGING SYSTEM. F/U PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78438 EON MINI SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3788 2849286

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3228