BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3161492 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-01645
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS ASSOCIATED WITH A FIELD CORRECTION. 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: 1627487-2013-1646. THE PATIENT HAS TWO LEADS IMPLANTED WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT WAS EXPERIENCING AN UNCOMFORTABLE HEATING SENSATION AT HER IPG SITE WHILE STIMULATION IS ON. IT WAS ALSO REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE STIMULATION AND HER LEADS ARE MORE SUPERFICIAL CAUSING DISCOMFORT. THE PATIENT IS NOT USING HER SCS SYSTEM AND IS REQUESTING TO HAVE IT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249281 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3593624

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention IMPLANT DATE:| SCS EXTENSION, MODEL 3386 (2)