BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2792220 · Received October 10, 2012

    Report

    Report Number
    1627487-2012-11455
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 17, 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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PT NO LONGER HAD STIMULATION AND THE IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. THE SJM REPRESENTATIVE MET WITH THE PT AND CONFIRMED THE ISSUE. FOLLOW UP IDENTIFIED THE PHYSICIAN WAS TO UNDERTAKE SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3308943

    Patients

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