BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2792148 · Received October 11, 2012

    Report

    Report Number
    1627487-2012-02483
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    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

    IT WAS REPORTED THE PT FELT THE IPG HEATING UP WHENEVER THE SYSTEM WAS ON. HE STATED THE SITE GETS RED OR HOT AND HE HAS TO TURN STIMULATION OFF AFTER A COUPLE OF HOURS TO LET THE SENSATION SUBSIDE. F/U IDENTIFIED THE HEATING SENSATION HAD DIMINISHED AND WAS NO LONGER AN ISSUE FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3751681

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3228