BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 8 PADDLE LEAD

    MDR report key: 1825932 · Received August 31, 2010

    Report

    Report Number
    1627487-2010-01992
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    July 28, 2010
    Report Date
    August 2, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: A VISUAL EXAMINATION AND FUNCTIONAL TESTING WERE PERFORMED ON THE LED. THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: VISUAL INSPECTION SHOWED MULTIPLE INSTRUMENT MARKINGS ON THE OUTER TUBING AND SEPARATION ABOVE THE INSERTION HANDLE ON THE TERMINAL END. THERE WAS ALSO SPACER COMPRESSION DAMAGE BETWEEN ELECTRODE 8 AND INSERTION HANDLE ON TERMINAL END. THE LEAD PASSED THE CONTINUITY TEST AS WELL AS THE RESISTIVITY TEST, WITH ALL CHANNELS MEASURING LESS THAN 4 OHMS. THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE COMPLAINT WAS NOT CONFIRMED FOR "LEAD BROKEN / FRACTURED". THE LEAD PASSED CONTINUITY AND RESISTIVITY TESTS. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS 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. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2006, THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM. THE PATIENT WAS IN A CAR WRECK AND HIS STIMULATION WOULD NOT WORK AFTER THAT. THE WRECK FRACTURED THE LEAD AND THE PATIENT LOST STIMULATION. THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 8 PADDLE LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3280 38860

    Patients

    Seq Age Sex Outcome Treatment
    1 Other