BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON PATIENT PROGRAMMER

    MDR report key: 3082294 · Received April 16, 2013

    Report

    Report Number
    1627487-2013-05541
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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

    IT WAS REPORTED THE PATIENT EXPERIENCED OVERSTIMULATION WHEN HE ATTEMPTED TO INCREASE STIMULATION. IT WAS ALSO REPORTED THE PATIENT EXPERIENCED DIFFICULTY DEACTIVATING STIMULATION WHILE USING THE PROGRAMMER. THE PATIENT UNDERWENT TROUBLESHOOTING WITH AN SJM REPRESENTATIVE AND IS DOING WELL AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163221 EON PATIENT PROGRAMMER SCS PROGRAMMER LGW ST. JUDE MEDICAL - NEUROMODULATION 3851 3895084

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788