BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4112686 · Received September 10, 2014

    Report

    Report Number
    1627487-2014-05647
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE PATIENT HAS AN SCS SYSTEM FOR OFF-LABEL USE. IT WAS REPORTED THE PATIENT EXPERIENCED PAIN/DISCOMFORT AT THE IPG SITE THAT RADIATED DOWN HIS LEGS. AS A RESULT, THE PATIENT'S IPG WAS RELOCATED ON (B)(6) 2014. RELOCATING THE IPG RESOLVED THE PATIENT'S ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559609 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 4120906

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other IMPLANT DATE:| IMPLANT DATE:| SCS ANCHORS: MODEL 1194| SCS LEADS: MODEL 3190