BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3032285 · Received March 29, 2013

    Report

    Report Number
    1627487-2013-01372
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBERS: 1627487-07262012-002-R AND 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS 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 IS EXPERIENCING SOME DISCOMFORT OR OCCASIONAL SHARP BURNING PAIN STARTING AT HER IPG SITE AND SPREADING OVER THE SURROUNDING AREA. THE PT IS PENDING F/U WITH AN SJM REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130081 EON MINI SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3788 174693

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention IMPLANT DATE:| SCS EXTENSION: MODEL 3383 (2)| IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)| SCS LEAD: MODEL 3186 (2)| IMPLANT DATE: