BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8 LEAD

    MDR report key: 1870837 · Received October 6, 2010

    Report

    Report Number
    1627487-2010-02708
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    May 24, 2010
    Report Date
    September 7, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT #2831909. METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION - 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) 2009, THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM WHICH INCLUDED TWO SURGICAL LEADS. ON (B)(6) 2010, IT WAS REPORTED THAT THE PATIENT SUDDENLY LOST ALL STIMULATION. THE IMPEDANCE ON ALL CONTACTS WERE INVALID ON ONE OF THE LEADS. THE LEADS WERE EXPLANTED AND REPLACED ON (B)(6) 2010. THE EXPLANTED LEADS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. FOLLOW-UP ON THE PATIENT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S8 LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3286 2822547

    Patients

    Seq Age Sex Outcome Treatment
    1 Other