BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44

    MDR report key: 4151794 · Received October 6, 2014

    Report

    Report Number
    1627487-2014-12655
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS: MICROSCOPIC INSPECTION OF THE RETURNED LAMITRODE LEAD FOUND THAT THE TERMINAL END OF THE LEAD WAS CUT OFF OF THE LEAD BODY. LEAVING THE LEAD IN TWO PIECES, THE STIMULATION SEGMENT END AND THE TERMINAL SEGMENT END. THE TERMINAL END SEGMENT WAS IN FAIR CONDITION, CONTACTS WERE IN GOOD CONDITION, GREEN DEBRIS WAS OBSERVED FROM A COATED STYLET AND THE TERMINAL END SEGMENT WAS SHORT. UNABLE TO TEST SEGMENT FOR CONTINUITY, SEGMENT WAS TOO SHORT. MICROSCOPIC INSPECTION OF THE STIMULATION END SEGMENT OF THE LEAD FOUND SEVERAL DAMAGED AREAS IN THE LEAD BODY, WITH TUBING BREACHES FROM THE EXPLANT PROCEDURE. THERE WERE ALSO MULTIPLE BROKEN INTERNAL WIRES IN THE STIMULATION (PADDLE) END OF THE LEAD. 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 PT WAS NO LONGER RECEIVING EFFECTIVE STIMULATION THERAPY IN THE CORRECT LOCATION. THE LEAD WAS EXPLANTED AND REPLACED IN A NEW LOCATION. THE PHYSICIAN ELECTIVELY REMOVED AND REPLACED THE IPG DURING THE PROCEDURE. THERE WERE NO COMPLAINTS ON THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623318 LAMITRODE 44 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3264 116501

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other