BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE 3/4 PERCUTANEOUS LEADS

    MDR report key: 1791850 · Received August 4, 2010

    Report

    Report Number
    1627487-2010-01843
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    April 15, 2010
    Report Date
    April 15, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRECISE LOT NUMBER OF THE LEAD IS UNKNOWN SO RECORD REVIEWS WERE PERFORMED ON ALL POSSIBLE LOT NUMBERS. THE LEAD WAS VISUALLY INSPECTED AND FUNCTIONAL TESTING WAS PERFORMED. THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE LEAD HAD BROKEN WIRES ABOUT 23CM AWAY FROM THE STIMULATION END. THERE WERE ALSO INSTRUMENTATION MARKINGS 23CM, 24CM, AND 35CM AWAY FROM THE STIMULATION END. CONTINUITY TESTING FAILED AS ALL WIRES WERE BROKEN AND STRESS TESTING WAS UNABLE TO BE PERFORMED. CONCLUSION: THE COMPLAINT ABOUT "INEFFECTIVE STIMULATION" WAS CONFIRMED. AS RECEIVED, IT WAS OBSERVED THAT THE LEAD HAS BROKEN WIRES IN THE LEAD SEGMENT. THE CAUSE OF THE INSTRUMENT MARKINGS IS UNKNOWN AND COULD NOT BE DETERMINED. 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. THE PATIENT¿S SYSTEM WAS AUTO-REDUCING ON ALL 6 PROGRAMS. THE REPRESENTATIVE MET WITH THE PATIENT AND TRIED TO REPROGRAM THE PATIENT TO RECAPTURE STIMULATION. ON (B)(6) 2010, THE PATIENT HAD ONE OF HER LEADS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 3/4 PERCUTANEOUS LEADS SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3186

    Patients

    Seq Age Sex Outcome Treatment
    1 Other