BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2780288 · Received October 5, 2012

    Report

    Report Number
    1627487-2012-02435
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    August 29, 2012
    Report Date
    September 12, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 4 OF 4: REFERENCE MFR REPORTS: 1627487-2012-02432, 02433, 02434. IT WAS REPORTED, THE PATIENT ONLY FELT STIMULATION AT HER IPG POCKET SITE AND IN HER TOES. SHE REPORTED, SHE WAS EXERCISING ABOUT TWO WEEKS AGO AND SUBSEQUENTLY HER STIMULATION PATTERN CHANGED. SHE ALSO REPORTED, SHE FEELS A LUMP IN HER MID-BACK NEAR HER LEAD INCISION SITE. AN X-RAY SHOWED ONE OF THE PATIENT'S LEADS HAD MIGRATED INFERIORLY. IT WAS REPORTED SURGICAL INTERVENTION WILL BE UNDERTAKEN AT A LATER DATE TO ADDRESS THE ISSUE. ACCORDING TO THE MANUFACTURER'S DEVICE REGISTRATION SYSTEM, THE PATIENT WAS IMPLANTED WITH THREE LEADS. THE IMPLANT DATES ARE CURRENTLY UNKNOWN; THEREFORE, ALL LEADS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3410924

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention