BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3960201 · Received July 23, 2014

    Report

    Report Number
    1627487-2014-23484
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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. REF MFR REPORT #1627487-2014-23485. THE PT HAS 2 LEADS (FROM THE SAME LOT) IMPLANTED AS PART OF HIS SCS SYSTEM. THE PT REPORTED HE INITIALLY FELT VERY ADEQUATE STIMULATION WITH HIS SCS SYSTEM. HOWEVER, IT GRADUALLY CHANGED AND HE NOW FEELS PAIN AT THE IPG SITE. IN ADDITION, THE PT STATED HIS LEGS FEEL COLD AS IF HIS BLOOD IS NOT CIRCULATING PROPERLY. THE PT FEELS AS IF THE SCS SYSTEM IS NO LONGER BENEFICIAL TO HIM. SUBSEQUENTLY, THE PT DESIRES TO UNDERGO SURGICAL INTERVENTION AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429829 EON MINI SCS IPG GZB ST JUDE MEDICAL - NEUROMODULATION 3788 3735005

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)