BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2971013 · Received February 15, 2013

    Report

    Report Number
    1627487-2013-01167
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 7, 2012
    Report Date
    January 21, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FILED ADVISORY. SJM HAS LIMITED INFORMATION 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 PATIENT IS NO LONGER RECEIVING STIMULATION AND IS UNABLE TO COMMUNICATE WITH OR CHARGE HIS IPG. AN SJM REPRESENTATIVE MET WITH THE PATIENT AND CONFIRMED THE ISSUE. THE PATIENT IS CONSIDERING IPG REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69766 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3121735

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3186 (2)| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE: