BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3052239 · Received April 4, 2013

    Report

    Report Number
    1627487-2013-02474
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 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
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 DEVICE "QUIT WORKING" APPROX 2 YEARS AGO AND HAD NEVER HELPED THE PT'S PAIN DESPITE ADJUSTMENTS TO THE SETTINGS. IT WAS REPORTED THE PT HAS EXPERIENCED OTHER MEDICAL ISSUES AS WELL AS SEVERAL FALLS DUE TO WEAKNESS. THE PT IS SCHEDULED TO HAVE HIS SYSTEM REMOVED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139170 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 84647

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention