BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXXESS QUAD 3/6 PERCUTANEOUS LEAD

    MDR report key: 1791819 · Received August 4, 2010

    Report

    Report Number
    1627487-2010-01808
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    April 23, 2010
    Report Date
    April 23, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION 1 OF 2. PLEASE SEE MFR REPORT # 1627487-2010-01963 FOR EVALUATION OF DEVICE 2. EVALUATION: METHOD: VISUAL AND FUNCTIONAL TESTS WERE PERFORMED ON THE RETURNED LEAD. THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE RETURNED LEAD WAS INCOMPLETE ALTHOUGH NO OTHER VISIBLE ANOMALIES WERE NOTED. THIS PREVENTED FUNCTIONAL TESTS FROM BEING COMPLETED. THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CLAIM ABOUT "NO STIMULATION," COULD NOT BE CONFIRMED. THE LEAD, AS RETURNED, WAS INCOMPLETE AND COULD NOT BE ANALYZED. 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

    DEVICE 1 OF 2. PLEASE SEE MFR REPORT # 1627487-2010-01963 FOR DEVICE 2. ON (B)(6) 2008, THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM. IN (B)(6) 2010, THE PT NOTICED THE STIMULATION WAS GONE. THE PROGRAMMER CAN LOCATE THE IPG AND REPROGRAMMING WAS ATTEMPTED BUT NOTHING WILL PRODUCE STIMULATION. THE IMPEDANCES ALL SHOW INVALID. THE PATIENT HAD NOT FALLEN OR HAD ANY MEDICAL TESTS OR PROCEDURES. ON (B)(6) 2010, THE PATIENT¿S SYSTEM WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXXESS QUAD 3/6 PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 4156 85228

    Patients

    Seq Age Sex Outcome Treatment
    1 Other