BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4091860 · Received August 28, 2014

    Report

    Report Number
    1627487-2014-02594
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    July 18, 2014
    Report Date
    August 8, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION NUMBER: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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 TURNED HER SCS STIMULATION OFF APPROXIMATELY THREE WEEKS AGO TO HAVE A MEDICAL PROCEDURE UNRELATED TO HER SCS SYSTEM. THE PATIENT STATED SHE HAS BEEN UNABLE TO TURN HER STIMULATION ON SINCE THE PROCEDURE. THE PATIENT STATED HER SCS IPG CHARGER AND THE PATIENT PROGRAMMER DO NOT COMMUNICATE WITH HER IPG. A SJM REPRESENTATIVE MET WITH THE PATIENT AND CONFIRMED THE PATIENT'S SCS IPG DOES NOT COMMUNICATE WITH EXTERNAL DEVICES. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526480 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2772508

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other SCS LEAD: MODEL 3186| IMPLANT DATE: