BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3961192 · Received July 15, 2014

    Report

    Report Number
    1627487-2014-05499
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 23, 2013
    Report Date
    June 23, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    IT WAS REPORTED THE PATIENT HAS BEEN EXPERIENCING DISCOMFORT/PAIN AT THE IPG SITE. AS A RESULT, THE PATIENT WOULD LIKE TO UNDERGO SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413169 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3560550

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other IMPLANT:| SCS ANCHORS, MODEL: 1192 (X3)| IMPLANT:| SCS LEAD, MODEL: 3286| IMPLANT:| SCS EXTENSION, MODEL: 3341| IMPLANT:| SCS LEADS, MODEL: 3146 (X2)