BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2926053 · Received January 17, 2013

    Report

    Report Number
    1627487-2013-05096
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. SJM HAS LIMITED INFO 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 PT HAD FALLEN AND AFTERWARDS STOPPED MAINTAINING THE IPG AS RECOMMENDED. AS A RESULT, THE PT LOST STIMULATION. IT WAS ALSO REPORTED THE CHARGER AND PROGRAMMER CAN NO LONGER COMMUNICATE WITH THE IPG. THE PT MAY UNDERGO X-RAYS AND SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26819 EON MINI SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3788 3290655

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention SCS LEADS: MODEL 3186 (X2)| IMPLANT:| IMPLANT:| SCS ANCHORS: MODEL 1192 (X2)