BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4173857 · Received October 10, 2014

    Report

    Report Number
    1627487-2014-02717
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 4, 2014
    Report Date
    September 18, 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
    OR, 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

    IT WAS REPORTED, THE PATIENT EXPERIENCES HIS SCS IPG TURNING OFF WITHOUT PROMPTING. A SJM REPRESENTATIVE MET WITH THE PATIENT, HOWEVER, TROUBLESHOOTING COULD NOT IDENTIFY THE SOURCE OF THE ISSUE. THE PATIENT STATED, THE ISSUE IS A DAILY OCCURRENCE AND SOMETIMES IT HAPPENS MULTIPLE TIMES A DAY. FOLLOW-UP IDENTIFIED THE PATIENT'S IPG WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643162 EON MINI SCS IPG GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3788 4296244

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other IMPLANT:| SCS ANCHOR: MODEL 1192 (X2)| IMPLANT:| SCS LEAD: MODEL 3186 (X2)