BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLAIM 8 SURGICAL LEAD

    MDR report key: 1870778 · Received September 22, 2010

    Report

    Report Number
    1627487-2010-02539
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 27, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC
    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

    EVALUATION, RESULTS: UNAPPROVED USE OF THE DEVICE. LAMITRODE A HAS DISCOLORATION ON THE ELECTRODES AT THE TERMINAL END. CONTINUITY TESTING PASS FOR LAMITRODE A. ALL CHANNELS MEASURE LESS THAN 10 OHMS. STRESS TESTING DOES NOT REVEAL ANY OTHER FAILURES. NO OTHER ANOMALIES WERE FOUND. CONCLUSION: COMPLAINT ABOUT "LEAD MIGRATION" CANNOT BE CONFIRMED THROUGH LAB TESTING, HOWEVER THE LEAD IS FUNCTIONAL. ANS HAS LIMITED INFORMATION 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. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2 (LAMITRODE A). SEE MFR# 1627487-2010-02711. ON (B)(6) 2010, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. THE LEAD MIGRATED AND THE PT COULD ONLY GET STIMULATION IN ONE HALF OF THE HEAD AND THEY NEEDED IT ON BOTH SIDES. BOTH LEADS WERE REMOVED AND REPLACED. THE PT HAS HAD GREAT STIMULATION POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCLAIM 8 SURGICAL LEAD SPINAL CORD, IMPLANTABLE (PAIN RELIEF) LGW ADVANCED NEUROMODULATION SYSTEMS, INC 3225 2847821

    Patients

    Seq Age Sex Outcome Treatment
    1 Other