BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1790842 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01674
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    November 7, 2007
    Report Date
    November 12, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. EON AS RECEIVED FAILS FUNCTIONAL TESTING AND APPEARS THE 1.3 UCOD U2 HAS FAILED. PROBLEM WAS TRACED TO CAPACITOR C29. WHEN THIS CAPACITOR WAS REPLACED, THE IPG FUNCTIONED NORMALLY WITH NO SIGNS OF INTERMITTENCY OF THE OUTPUTS. CAPACITOR WAS CHECKED WITH A LCR METER AND MEASURES TO BE IN TOLERANCE (1.09UF). UNIT WAS TESTED ON THE AUTOTESTER AND PASSED ALL TESTS. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. (B)(4). 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

    THE PATIENT RECEIVED HIS SCS SYSTEM INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS ON (B)(6) 2007. IT WAS REPORTED THE DEVICE WAS EXPLANTED AND REPLACED DUE TO LOW IMPEDANCE MEASUREMENTS AND THE PATIENT CEASED TO RECEIVE STIMULATION. THE IPG WAS EXPLANTED AND RETURNED TO ANS FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3716 65584

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention