BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3141962 · Received May 28, 2013

    Report

    Report Number
    1627487-2013-13790
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    December 21, 2010
    Report Date
    April 30, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS 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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT: 1627487-2013-13791. THE PATIENT REPORTED SHE HAD NEVER CHARGED HER IPG. IN ADDITION, THE PATIENT REPORTED SHE HAD NEVER RECEIVED EFFECTIVE STIMULATION THERAPY, SINCE SHE HAD NEVER RECEIVED STIMULATION IN HER LOWER BACK WHERE IT WAS NEEDED. TWO DIFFERENT CHARGING SYSTEMS WERE UNABLE TO COMMUNICATE WITH THE IPG. IT WAS REPORTED THE PATIENT WANTED THE SCS SYSTEM TO BE REMOVED. THE PATIENT WAS TO CONTACT A PHYSICIAN, AND THE SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A LATER DATE TO REMOVE THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233267 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3229703

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention