BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2940681 · Received January 30, 2013

    Report

    Report Number
    1627487-2013-02154
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 10, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    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 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

    THE PT RECEIVED AN IPG AND COMPETITOR'S LEADS AS PART OF HER SCS SYSTEM. IT WAS REPORTED THE PHYSICIAN REMOVED THE ENTIRE SYSTEM AND TWO NEW SYSTEMS WERE IMPLANTED. THE REASON FOR THE EXPLANT IS CURRENTLY UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40288 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3308486

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention