BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4212888 · Received October 24, 2014

    Report

    Report Number
    1627487-2014-12713
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ST. JUDE MED - NEUROMODULATION
    Product Code
    GZB
    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

    DEVICE 1 OF 3. REFERENCE MFR REPORT #1627487-2014-12714. REFERENCE MFR REPORT #1627487-2014-12715. NOTE DEVICE 2 & 3 WERE PLACED OCCIPITAL (OFF LABEL USE) IT WAS REPORTED THE PATIENT HAD TWO SEIZURES IN A WEEK, WITH THE STIMULATION ON. THE PATIENT WAS SEEN BY THE PHYSICIAN WHO PRESCRIBED ANTI-SEIZURE MEDICATION. REPORTEDLY THE PHYSICIAN DOES NOT BELIEVE THE ISSUE WAS CAUSED BY THE SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678625 OCTRODE SCS LEAD GZB ST. JUDE MED - NEUROMODULATION 3189 3406221

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR IMPLANT DATE:| SCS EXTENSION: MODEL 3346| IMPLANT DATE:| SCS IPG: MODEL 3788