BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3142196 · Received May 29, 2013

    Report

    Report Number
    1627487-2013-01610
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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

    THE PATIENT HAD TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT DROPPED THE MTS WHICH RESULTED IN THE END OF THE OCCIPITAL LEAD BREAKING OFF. THE PATIENT WAS IMPLANTED WITH OCCIPITAL AND SUPRAORBITAL (OFF LABEL USE) TRIAL LEADS. THE PATIENT'S LEADS WERE PULLED ON (B)(6) 2013. THE PATIENT WAS LATER IMPLANTED WITH A PERMANENT SCS SYSTEM ON (B)(6) 2013 AND IS RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237304 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3961838

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention