BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2772020 · Received October 2, 2012

    Report

    Report Number
    1627487-2012-02411
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    August 4, 2012
    Report Date
    August 4, 2012
    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 THE PATIENT WAS SCHEDULED TO RECEIVE A SCS TRIAL SYSTEM; HOWEVER, THE PROCEDURE WAS ABORTED PRIOR TO ACCESSING THE PATIENT'S EPIDURAL SPACE. IT WAS REPORTED THE PATIENT COULD NOT TOLERATE THE PROCEDURE AS SHE WAS EXTREMELY UNCOMFORTABLE AFTER SHE WAS GIVEN SEDATION. THE PHYSICIAN DECIDED TO RESCHEDULE THE SURGERY AT A DIFFERENT LOCATION WHERE SHE COULD BE GIVEN APPROPRIATE SEDATION PRIOR TO ACCESSING THE EPIDURAL SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3183 3648926

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention