BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4092063 · Received September 3, 2014

    Report

    Report Number
    1627487-2014-08236
    Event Type
    Injury
    Date Received
    September 3, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 11, 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 PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S INTERNAL STITCHES CAME LOOSE AT HIS SCS IPG SITE. THE PT IS FOLLOWING UP WITH HIS PHYSICIAN TO DETERMINE ANY NECESSARY NEXT STEPS TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535454 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 4529314

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other IMPLANT DATE:| SCS IPG: MODEL 3228