BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3850384 · Received May 30, 2014

    Report

    Report Number
    1627487-2014-02380
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    DEVICE 1 OF 2. REF MFR REPORT# 1627487-2014-02381. IT WAS REPORTED THE PT WAS WITHOUT STIMULATION DUE TO THE PT'S SCS LEAD POSSIBLY PULLING OUT OF THE SCS IPG HEADER. FOLLOW UP ON (B)(6) 2014 IDENTIFIED THE PT'S IPG WAS REMOVED ON (B)(6) 2014. THE PT WILL UNDERGO A BATTERY REPLACEMENT AND A FULL REVISION OF HER SCS SYSTEM AT A LATE DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319860 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3537876

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other