BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3110706 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-01518
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 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

    IT WAS REPORTED DURING A TRIAL IMPLANT PROCEDURE, THE PHYSICIAN WAS UNABLE TO STEER THE LEAD TO PLACE IT PROPERLY. THE PATIENT EXPERIENCED PAIN AFTER MULTIPLE ATTEMPTS TO PLACE THE LEAD, AND THE PROCEDURE WAS ABANDONED. THE PATIENT WAS REFERRED FOR A PADDLE LEAD TRIAL. THE PATIENT IS NO LONGER EXPERIENCING PAIN FROM THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208104 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3888245

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention