BEUDAMED
    FDA Adverse Event Other Summary report: N

    OCTRODE TRIAL PERCUTANEOUS LEAD

    MDR report key: 1527016 · Received November 10, 2009

    Report

    Report Number
    1627487-2009-00059
    Event Type
    Other
    Date Received
    November 10, 2009
    Date of Event
    October 13, 2009
    Report Date
    October 13, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD - THE DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS - THE DISTAL TIP OF THE END ELECTRODE WAS MISSING JUST BELOW THE JUNCTION WHERE THE TIP AND TRANSITION SLEEVE ARE WELDED ONTO THE ELECTRODE. OTHERWISE, VISUALLY THE LEAD SEGMENT WAS CLEAR AND UNDAMAGED. ALL LEAD CHANNELS PASSED CONTINUITY TESTING. THE LEAD PASSED FUNCTIONAL TESTING. THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWS WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. CONCLUSION: IT IS INCONCLUSIVE WITHOUT THE MISSING TIP TO DETERMINE IF THE WELD OR SOME OTHER FACTOR SUCH AS LEAD SKIVING FROM THE HEEL OF THE NEEDLE WAS INVOLVED IN THE TIP BREAKAGE. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. THE LEAD DIRECTION-FOR-USE CONTAINS A WARNING THAT STATES "IF PULLING THE LEAD BACK THROUGH THE NEEDLE, USE CAUTION TO AVOID SEVERE DAMAGE TO THE LEAD DUE TO SHEARING FROM THE NEEDLE'S TIP". ANS HAS LIMITED INFO RELATED TO THE PT'S MED HISTORY AND HIS 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 MED HISTORY.

    Description of Event or Problem · 1

    ANS RECEIVED A REPORT, THAT DURING THE PLACEMENT OF A TRIAL LEAD THAT ELECTRODE NUMBER ONE BROKE IN HALF, AND HALF OF THE CONTACT IS STILL IMPLANTED. THE ELECTRODE FRAGMENT WAS BROKEN OFF SUBCUTANEOUS AROUND T12/L1. THE FRAGMENT LOCATION WAS CONFIRMED BY IMAGING AND WILL NOT BE REMOVED. TECHNICAL SUPPORT WILL SEND THE SURGEON A LETTER THAT INCLUDES A COPY OF THE JAN 15, 2008, PUBLIC HEALTH NOTIFICATION ISSUED BY FDA TITLED, "FDA PUBLIC HEALTH NOTIFICATION: UNRETRIEVED DEVICE FRAGMENTS." THE LEAD WAS RECEIVED BY ANS ON 10/22/2009, DECONTAMINATED AND EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE TRIAL PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3086 2841252

    Patients

    Seq Age Sex Outcome Treatment
    1 Other