BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3012259 · Received March 12, 2013

    Report

    Report Number
    1627487-2013-03359
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 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 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-03360. IT WAS REPORTED THE PT EXPERIENCED A FALL. SUBSEQUENTLY, THE PT IS EXPERIENCING A BURNING SENSATION FROM HER SPINE TO HER SCS IPG POCKET SITE REGARDLESS OF STIMULATION. F/U IDENTIFIED AT THIS TIME, NO ACTION WILL BE TAKEN TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104252 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 171703

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention