BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON 16-CHANNEL IPG

    MDR report key: 1873511 · Received September 22, 2010

    Report

    Report Number
    1627487-2010-02554
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    July 9, 2010
    Report Date
    August 24, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: A VISUAL EXAMINATION AND FUNCTIONAL TESTING WERE PERFORMED. THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE VISUAL INSPECTION REVEALED INSTRUMENT MARKS ON THE CAN AND DISCOLORATION ON THE TOP HEADER. THE IPG SUCCESSFULLY COMMUNICATED WITH A LAB PT PROGRAMMER BUT SHOWED "IPG BATTERY LOW, STIM OFF" WARNING MESSAGE. THE IPG WAS PLACED ON THE CHARGER AND COMMUNICATION WAS ESTABLISHED AND THE IPG WAS FULLY CHARGED. THE IPG WAS TESTED ON THE AUTO-TESTER AND PASSED. THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE COMPLAINT COULD NOT BE CONFIRMED FOR "CHARGER CAN'T LOCATE IPG." THE RETURNED IPG SUCCESSFULLY COMMUNICATED WITH A LAB CHARGING SYSTEM. THE CHARGING SYSTEM CHARGED THE IPG TO FULL CHARGE. THE IPG ALSO COMMUNICATED WITH A LAB PT PROGRAMMER AND PASSED AUTO-TESTING. 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 PT'S MEDICAL HISTORY AND IS 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 MEDICAL HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2006, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. THE PT'S IPG WOULD NO LONGER COMMUNICATE WITH CHARGER. NO GAUZE, SWELLING, STAPLES, OR WEIGHT GAIN/LOSS WERE PRESENT. THE REP TRIED ADDING/SUBTRACTING SPACE AND REPOSITIONING ANTENNA BUT WAS STILL UNSUCCESSFUL. A NEW CHARGER WAS TRIED WITH ALL THE SAME TROUBLESHOOTING TECHNIQUES WITH THE SAME RESULT. THE IPG WAS NOT FLIPPED AND IT COULD STILL COMMUNICATE WITH THE PROGRAMMER. ON (B)(6) 2010, THE IPG WAS EXPLANTED AND REPLACED WITH AN EON MINI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16-CHANNEL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS INC. 3716 56159

    Patients

    Seq Age Sex Outcome Treatment
    1 Other