BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2792004 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-12275
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 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

    EVAL CODES: RESULTS: THE COMPLAINT FOR DISCOMFORT WAS NOT CONFIRMED. AS RECEIVED, THE LEAD WAS IN GOOD CONDITION AND PASSED ALL FUNCTIONAL TESTS. NO ANOMALIES WERE OBSERVED THAT WOULD CONTRIBUTE TO THE COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TRIAL PROCEDURE, THE PT REPORTED TINGLING IN BOTH LEGS WHEN THE LEAD WAS INTRODUCED INTO THE EPIDURAL SPACE. THE SJM REP REPORTED THE LEAD WAS REMOVED AND THE TRIAL WAS ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3770619

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention