BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3240431 · Received July 18, 2013

    Report

    Report Number
    1627487-2013-11055
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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

    ON (B)(6) 2013, THE PATIENT'S IPG WAS RELOCATED DUE TO PAIN/DISCOMFORT AT THE POCKET SITE. AN EXTENSION WAS ALSO IMPLANTED DUE TO THE RELOCATION OF THE IPG. RELOCATING THE IPG RESOLVED THE PATIENT'S ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336360 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3535754

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other SCS LEAD, MODEL: 3228| IMPLANT: