BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2894927 · Received December 20, 2012

    Report

    Report Number
    1627487-2012-11884
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 1, 2012
    Report Date
    December 1, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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

    THE PT RECEIVED TWO TRIAL LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED ONE OF THE WIRES WAS CAUGHT IN BETWEEN THE SEAT WHILE GETTING OUT OF AN AUTOMOBILE, AND THE PT FELT A PULL DOWNWARD. THE PT REPORTED AFTERWARD SHE FELT DISCOMFORT WHILE BREATHING. THE PT TURNED THE SYSTEM OFF. THE ON CALL PHYSICIAN ADVISED THE PT TO GO TO THE ER. THE PT DECIDED TO WAIT FOR THE IMPLANTING PHYSICIAN TO EXPLANT THE LEADS. IT WAS REPORTED THE PT HAD RECEIVED EFFECTIVE STIMULATION, AND THE ISSUES WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS TRIAL LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3799177

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention