BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2843386 · Received November 15, 2012

    Report

    Report Number
    1627487-2012-03720
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    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 INFORMATION 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

    IT WAS REPORTED THE PATIENT EXPERIENCES WARMING AT HIS SCS IPG POCKET SITE WHILE USING SYSTEM STIMULATION FOR LONG PERIODS OF TIME. THE PATIENT HAS LOST SOME WEIGHT, AND THE SCS IPG IS MORE PROMINENT THAN IT USED TO BE. FOLLOW-UP IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3715792

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention SCS ANCHOR, MODEL 1192 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD, MODEL 3183 (2)