BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2843402 · Received November 15, 2012

    Report

    Report Number
    1627487-2012-03724
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    April 23, 2011
    Report Date
    October 23, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 PAIN FROM HER SCS IPG PRESSING AGAINST HER SCIATIC NERVE ON HER LEFT SIDE. THE PAIN OCCURS WITH AND WITHOUT SYSTEM STIMULATION. ADDITIONALLY, ONE CORNER OF THE PATIENT'S SCS IPG STICKS OUT. THE PATIENT DESIRES TO HAVE HER SCS SYSTEM REMOVED AND WILL BE CONSULTING WITH THE PHYSICIAN. FOLLOW-UP IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 2898574

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention SCS LEAD, MODEL 3186 (2)| IMPLANT DATE: