BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 1881814 · Received October 8, 2010

    Report

    Report Number
    1627487-2010-02634
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, 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 AND NO ANOMALIES WERE FOUND. LEAD FRAGMENT WAS FOUND IN THE IPG HEADER. CONCLUSION: THE REPORTED COMPLAINT WAS CONFIRMED; AS RECEIVED THE IPG HAS A TERMINAL END ELECTRODE BROKEN OFF INSIDE THE LOWER HEADER PORT. THE IPG PASSES ALL FUNCTIONAL TESTS. 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) 2010, THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM. ON (B)(6) 2010, IT WAS REPORTED THAT DURING A LEAD REVISION PROCEDURE WHEN THE DOCTOR REMOVED THE LEAD FROM THE IPG HEADER, THE FIRST LEAD CONTACT BROKE OFF IN THE IPG HEADER. THE DOCTOR SUBSEQUENTLY REPLACED THE IPG AND LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3788 2926148

    Patients

    Seq Age Sex Outcome Treatment
    1 Other