BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3192087 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-02873
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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: 1627487-2013-02874. THE PT UNDERWENT AN IPG REPLACEMENT PROCEDURE ON (B)(6) 2013, AND HER IPG WAS IMPLANTED AT THE SAME POCKET SITE (REFERENCE MFR REPORT 1627487-2013-02432). IT WAS REPORTED THE PT STILL REPORTED POCKET HEATING WITH STIMULATION, AND THE ISSUE HAS OCCURRED SINCE HER IMPLANT. SHE STATED SHE FEELS BURNING AT HER IPG SITE AND BRA LINE SOON AFTER SHE TURNS ON A STIMULATION. SHE ALLEGED THE SENSATION SUBSIDES WHEN STIMULATION IS TURNED OFF. THE PT MENTIONED SHE HAS EXPERIENCED AN OCCASIONAL BURNING IN HER STOMACH WITH STIMULATION OFF. IT WAS ALSO REPORTED SHE HAS EXPERIENCED A SLIGHT HEAVINESS IN HER LEFT ARM SINCE APPROX (B)(6) 2013. THE PHYSICIAN ADVISED THE PT TO LEAVE STIMULATION OFF FOR 2 WEEKS AND SEE THE PHYSICIAN FOR A FOLLOW-UP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280517 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3968830

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other SCS EXTENSION: MODEL 3386 (2)| IMPLANT DATE: