BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3890740 · Received June 3, 2014

    Report

    Report Number
    1627487-2014-05406
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 HAS LOST WEIGHT. IN TURN, THE IPG IS UNABLE TO COMMUNICATE WITH THE CHARGER DUE TO THE IPG NOT BEING STATIONARY IN THE POCKET AND EXCESS SUBCUTANEOUS TISSUE. AS A RESULT, THE PT PLANS TO UNDERGO SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324406 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3339646

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other SCS LEAD: MODEL 3186| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHORS: MODEL 1192 (X3)| IMPLANT DATE:| SCS LEADS: MODEL 3146 (X2)| IMPLANT DATE:| SCS EXTENSION: MODEL 3341