BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 1840669 · Received September 17, 2010

    Report

    Report Number
    1627487-2010-02611
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 18, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS. THE IPG WAS VISUALLY INSPECTED AND IT WAS NOTED THAT THE TOP SEPTUM APPEARED TO BE CORED. THE IPG FAILED COMMUNICATION TESTING WITH THE LAB PT PROGRAMMER AND CHARGER. THE IPG BATTERY WAS EXAMINED AND NO LEAKAGE WAS NOTED. THE IPG WAS THEN POWERED WITH AN EXTERNAL POWER SOURCE AND RELOADED WITH THE BLUE SCREEN DEVICE. THE DEFAULT SETTINGS WERE RELOADED WITH THE HDI AUTO TEST. THE IPG THEN PASSED THE ANS AUTO TEST. CONCLUSION: THE REPORTED COMPLAINT WAS CONFIRMED. THE IPG FAILED INITIAL COMMUNICATION TESTING WITH THE LAB EQUIPMENT. ANS HAS LIMITED INFO 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) 2008, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. ON (B)(6) 2010, IT WAS REPORTED THAT THE PT'S STIMULATION STOPPED AND THAT THE IPG WOULD NOT COMMUNICATE WITH THE CHARGER OR PT PROGRAMMER. THE PT WAS SENT ANOTHER PROGRAMMER AND CHARGER BUT NEITHER COULD COMMUNICATE WITH THE IPG. THE PT ADMITTED TO LETTING THE BATTERY RUN DOWN TO A MINIMUM BEFORE RECHARGING AND ONLY RECHARGING EVERY 5 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3788 172131

    Patients

    Seq Age Sex Outcome Treatment
    1 Other