BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2852299 · Received November 27, 2012

    Report

    Report Number
    1627487-2012-03767
    Event Type
    Injury
    Date Received
    November 27, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 REPORTED EXPERIENCING TENDERNESS AT HIS SCS IPG POCKET SITE WHEN HE WEARS PANTS DUE TO THE POSITION OF HIS SCS IPG (UNDER INCISION SITE). THE PATIENT ALSO REPORTED RECENTLY FALLING. X-RAYS ARE TO BE TAKEN. FOLLOW-UP IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3798550

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention IMPLANT DATE:| SCS ANCHOR, MODEL 1192 (2)| SCS LEAD, MODEL 3286 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION, MODEL 3383 (2)