BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3926308 · Received June 17, 2014

    Report

    Report Number
    1627487-2014-25450
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 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 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 NOT RECEIVING STIMULATION DUE TO THE LEADS SLIGHTLY DISCONNECTING FROM THE IPG HEADER. IN TURN, THE PT'S IPG WAS EXPLANTED AND REPLACED. INTRA-OP TESTING REVEALED NO ANOMALIES AND EFFECTIVE STIMULATION WAS RESTORED POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355943 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3715867

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other IMPLANT DATE:| SCS LEADS: MODEL 3186 (X2)| SCS ANCHORS: MODEL 1192 (X2)| IMPLANT DATE: