BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3192104 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-02852
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    December 29, 2008
    Report Date
    May 28, 2013
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):1627487-07262012-002-R. 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-02851. IT WAS REPORTED THE PATIENT FEELS A JOLTING SENSATION WHENEVER HE CHANGES POSITIONS OR COUGHS. HE ALLEGED THE ISSUE HAS OCCURRED SINCE IMPLANT REGARDLESS OF THE PROGRAM USED, AND IT IS MOST NOTICEABLE AT THE IPG SITE. X-RAYS AND DIAGNOSTIC TESTING REVEALED NO ANOMALIES. IT WAS REPORTED THE PHYSICIAN WAS AWARE OF THE ISSUE, AND NO INTERVENTION WILL BE TAKEN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281009 EON MINI SCS IPG LGW ST. JUDE MEDICAL NEUROMODULATION 3788 175272

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other