BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 4023675 · Received August 15, 2014

    Report

    Report Number
    1627487-2014-05591
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    June 1, 2014
    Report Date
    July 25, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. 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 PT HAS BEEN WITHOUT STIMULATION DUE TO THE CHARGER AND PROGRAMMER BEING UNABLE TO COMMUNICATE WITH THE IPG. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PT TO PROVIDE RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491426 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3290732

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR IMPLANT:| SCS LEADS, MODEL: 3186 (X2)| IMPLANT:| SCS ANCHORS, MODEL: 1192 (X2)