BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3031933 · Received March 28, 2013

    Report

    Report Number
    1627487-2013-00188
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 3, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 PT ((B)(6)) SUFFERS FROM MIGRAINES AND IS A PARTICIPANT IN A CLINICAL STUDY (OFF-LABEL). IT WAS REPORTED THE PT IS EXPERIENCING PAIN IN HER HEAD THAT IS NOT BEING ADDRESSED BY THE THERAPY SYSTEM. THE DISCOMFORT IS REPORTEDLY NOT ASSOCIATED WITH THE PT'S TARGETED PAIN AREA AND IS DESCRIBED AS BEING STRONGER ON THE RIGHT SIDE RUNNING TRANSVERSE FROM THE MIDDLE OF THE PT'S HEAD TO HER EAR. A RECENT CLINICAL ASSESSMENT FOUND NO ISSUES FROM A MEDICAL PERSPECTIVE. AN ADJUSTMENT TO HER STIMULATION WAS MADE AND THE PT WILL CONTINUE TO UTILIZE THE CURRENT THERAPY FOR THE IMMEDIATE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128010 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3189 3808580

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention SCS EXTENSION, MODEL 3383| IMPLANT DATE:| SCS IPG, MODEL UNK| IMPLANT DATE: