BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3821016 · Received May 7, 2014

    Report

    Report Number
    1627487-2014-26391
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ST. JUST 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 INFORMATION 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

    IT WAS REPORTED THE PHYSICIAN DURING A TRIAL PROCEDURE, THE PHYSICIAN WAS UNABLE TO ACCESS THE EPIDURAL SPACE TO IMPLANT THE TRIAL LEAD. AFTER MULTIPLE ATTEMPTS, THE PHYSICIAN DECIDED TO ABANDON THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276859 OCTRODE SCS LEAD GZB ST. JUST MEDICAL - NEUROMODULATION 3086 44224862

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other