BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4202508 · Received October 22, 2014

    Report

    Report Number
    1627487-2014-26875
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    October 1, 2012
    Report Date
    September 30, 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
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. SJM HAS LIMITED INFORMATION 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 HER IPG IS UNABLE TO COMMUNICATE WITH HER CHARGING SYSTEM. THE PT REPORTS SHE HAS NOT USED HER SCS SYSTEM IN TWO YEARS. THE SJM REPRESENTATIVE CONFIRMED THE ISSUE USING THE EXTERNAL DEVICES. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673536 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3179696

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)| IMPLANT DATE:| SCS ANCHOR: MODEL 1192(2)