BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3223142 · Received July 10, 2013

    Report

    Report Number
    1627487-2013-15942
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 19, 2013
    Report Date
    September 4, 2015
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    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 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-15941. IT WAS REPORTED THE PT EXPERIENCES A SHOCKING SENSATION IN HIS LEGS WHEN STIMULATION IS TURNED ON AND WHEN IT IS TURNED OFF. THE PT STATED THE SENSATION LASTS A COUPLE SECONDS. THE PT ALSO STATED THAT HE LOST APPROXIMATELY 15 POUNDS AND THE OUTLINE OF THE LEAD IS VISIBLE IN HIS BACK. DIAGNOSTIC TESTING REVEALED NO INVALID IMPEDANCE READINGS. THE NEXT COURSE OF ACTION IS UNDETERMINED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314887 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3819389

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male Other