BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE 8 EXTENSION

    MDR report key: 1880247 · Received October 19, 2010

    Report

    Report Number
    1627487-2010-02856
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND FOUND TO MEET SPECIFICATIONS; NO ANOMALIES WERE FOUND. THE EXTENSION WAS VISUALLY INSPECTED AND DISCOLORATION WAS OBSERVED IN THE EXTENSION LEAD SEGMENT AND SEPTUM. NO OTHER VISUAL ANOMALIES WERE NOTED. THE EXTENSIONS WERE SUBJECTED TO FUNCTIONAL TESTING AND PASSED CONTINUITY TESTING. ALL CHANNELS MEASURED LESS THAN 4 OHMS. STRESS TESTING DID NOT REVEAL ANY FAILURES. CONCLUSION: THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE EXTENSION PASSED ALL FUNCTIONAL TESTS. ANS HAS LIMITED INFO 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

    ON (B)(6)2008, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. ON (B)(6)2010, IT WAS REPORTED THAT THE PT FELT A BURNING SENSATION AT THE EXTENSION SITE. THE EXTENSION WAS EXPLANTED AND REPLACED. THE PT IS CURRENTLY SATISFIED WITH THE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE 8 EXTENSION SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3386 97493

    Patients

    Seq Age Sex Outcome Treatment
    1 Other