BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4060847 · Received August 6, 2014

    Report

    Report Number
    1627487-2014-26633
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    ST. JUDE MEDICAL, 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 INFO 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

    IT WAS REPORTED DURING A TRIAL PROCEDURE THE PHYSICIAN WAS UNABLE TO ACCESS THE EPIDURAL SPACE USING THE NEEDLE IN THE KIT DUE TO THE PATIENT HAVING LIGAMENT CALCIFICATION AND SEVERE STENOSIS. THE PROCEDURE WAS ABANDONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461050 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL, NEUROMODULATION 3086 4553907

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other