BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1791851 · Received August 4, 2010

    Report

    Report Number
    1627487-2010-01848
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 6, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. THE LEAD WAS VISUALLY INSPECTED AND AN ABNORMAL BEND WAS OBSERVED AS WELL AS BROKEN WIRES APPROXIMATELY 26 CM FROM THE STIMULATION END. NO OTHER ANOMALIES WERE NOTED. ALL CHANNELS ON THE LEAD MEASURED OPEN. NO ADDITIONAL FUNCTIONAL TESTING WAS PERFORMED DUE TO THE LEAD¿S BROKEN WIRES. CONCLUSION: THE REPORTED COMPLAINT WAS CONFIRMED. AS RECEIVED THE LEAD WAS SEVERELY KINKED WITH SEVERAL BROKEN WIRES. 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. ON (B)(6) 2010, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A GRADUAL DECLINE IN STIMULATION. THE CLINICAL SPECIALIST MET WITH THE PATIENT TO REPROGRAM THE DEVICE SETTINGS. THE SPECIALIST WAS UNABLE TO CAPTURE THE STIMULATION AND OBSERVED INVALID IMPEDANCE ON SEVERAL CONTACTS. AN X-RAY WAS TAKEN AND A SHARP BEND WAS NOTED AT THE ANCHOR. ON (B)(6) 2010, THE PHYSICIAN REPLACED THE PATIENT¿S LEAD. THE PATIENT IS CURRENTLY RECEIVING SATISFACTORY STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3186 98104

    Patients

    Seq Age Sex Outcome Treatment
    1 Other