BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3123953 · Received May 17, 2013

    Report

    Report Number
    1627487-2013-13761
    Event Type
    Malfunction
    Date Received
    May 17, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R,
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL REPORTING #: 1627487-07262013-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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

    THE PT REPORTED SHE HAD STOPPED USING HER SCS SYSTEM DUE TO PREGNANCY. THE PT HAS NOT CHARGED HER SYSTEM FOR OVER TWO YEARS AND CURRENTLY CANNOT COMMUNICATE WITH HER IPG USING EXTERNAL DEVICES. THE PT IS TENTATIVELY SCHEDULED FOR AN APPOINTMENT WITH A SJM REPRESENTATIVE AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219849 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2787778

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR SCS LEAD: MODEL 3186| IMPLANTED: