BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2993928 · Received March 1, 2013

    Report

    Report Number
    1627487-2013-02316
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 7, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    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

    THE PT UNDERWENT A PROCEDURE FOR A TRIAL SCS SYSTEM. IT WAS REPORTED THE PT DEVELOPED SYMPTOMS OF A HEADACHE AND VOMITING AFTER THE PROCEDURE. THE PT WENT TO THE HOSPITAL AND HER LEADS WERE REMOVED ON (B)(6) 2013. THE PT WAS TREATED WITH INTRAVENOUS FLUIDS AND WAS DISCHARGED WITH A COMPLETE RECOVERY OF SYMPTOMS. THE PHYSICIAN STATED THE ISSUE COULD HAVE BEEN RELATED TO POSSIBLE STENOSIS IN THE PT'S NECK, DEHYDRATION AND/OR SEDATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88719 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R