BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3001522 · Received March 5, 2013

    Report

    Report Number
    1627487-2013-06023
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 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 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

    IT WAS REPORTED THAT THE PT IS EXPERIENCING FREQUENT AND UNCOMFORTABLE POCKET HEATING WHETHER STIMULATION IS ON OR OFF. THE HEATING IS NOT RELATED TO CHARGING. F/U INDICATED THE PT'S PHYSICIAN REVIEWED THE PT'S MRI BEFORE THE IMPLANT AND WILL MOST LIKELY REPLACE THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94049 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3719475

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention SCS ANCHOR: MODEL 1194| IMPLANT DATE:| SCS LEAD: MODEL 3219| IMPLANT DATE: