BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3850409 · Received May 30, 2014

    Report

    Report Number
    1627487-2014-02382
    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
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 WAS EXPERIENCING DISCOMFORT AT HIS IPG SITE AND WOULD LIKE HIS SCS IPG MOVED. FOLLOW UP ON (B)(6) 2014 IDENTIFIED THE PT HAD HIS IPG POCKET REVISED ON (B)(6) 2014. THE PHYSICIAN MADE A NEW POCKET AND DECIDED TO ELECTIVELY REPLACE THE PT'S IPG WITH A DIFFERENT MODEL IPG. THERE WERE NO KNOWN ISSUES WITH THE PT'S ORIGINAL IPG. ADDITIONAL FOLLOW UP ON (B)(6) 2014 IDENTIFIED THE PT REPORTED HE IS NO LONGER EXPERIENCING PAIN AT THE IPG SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319833 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 4037575

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (X2)| IMPLANT DATE:| SCS LEAD: MODEL 3186 (X2)