BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3141965 · Received May 28, 2013

    Report

    Report Number
    1627487-2013-05736
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    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
    MS, 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 HAS BEEN EXPERIENCING SWELLING AND PAIN AT THE IPG SITE. IT WAS ALSO REPORTED THE PT HAS BEEN EXPERIENCING HEATING AT THE IPG SITE WHETHER STIMULATION IS ON OR OFF. AS A RESULT, THE PT WILL UNDERGO SURGICAL INTERVENTION ON A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233268 EON MINI SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3788 3315474

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SCS LEAD: MODEL 3228| IMPLANT:| IMPLANT:| SCS ANCHORS: MODEL 1192 (X2)