BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE TRIAL LEAD

    MDR report key: 1854073 · Received September 2, 2010

    Report

    Report Number
    1627487-2010-02442
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 13, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE 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) 2010, THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM. DURING THE SURGERY FOR THE PERMANENT IMPLANT OF THE IPG, THE SURGEON STATED A LEAD BREAKAGE OF THE LEAD THAT WAS IMPLANTED IN THE TRIAL. THE SURGEON TOLD SJM REPRESENTATIVE, THAT ALREADY DURING THE TRIAL, THE PATIENT HAD CLAIMED INTERRUPTIONS OF THE ELECTRICAL STIMULATION. THE BROKEN LEAD WAS EXPLANTED AND SUBSTITUTED WITH A NEW LEAD OF THE SAME MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE TRIAL LEAD SPINAL CORD, IMPLANTABLE, (PAIN RELIEF) LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3186

    Patients

    Seq Age Sex Outcome Treatment
    1 Other