BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3052341 · Received April 4, 2013

    Report

    Report Number
    1627487-2013-12450
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 15, 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 THE PT LOST STIMULATION AND THE CHARGER AND PROGRAMMER ARE UNABLE TO COMMUNICATE WITH THE IPG. THE SJM REPRESENTATIVE INTERROGATED THE SYSTEM AND WAS UNABLE TO ESTABLISH COMMUNICATION WITH EXTERNAL DEVICES. FOLLOW-UP DETERMINED THE IPG WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137795 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3504574

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention SCS LEAD: MODEL 3219| IMPLANT DATE: