BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1724698 · Received June 1, 2010

    Report

    Report Number
    1627487-2010-00843
    Event Type
    Malfunction
    Date Received
    June 1, 2010
    Date of Event
    December 19, 2008
    Report Date
    December 19, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    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

    EVAL: 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. IPG HAS INSTRUMENT MARKS ON THE HEADER, BACK CASE, AND ANTENNA SILICONE. THE HEADER AND ANTENNA SILICONE ARE BOTH CUT. THERE WERE NO ELECTRODES FOUND IN EITHER HEADER PORT. IPG PASSED FUNCTIONAL TESTING AND ALSO LEAD PULL TEST (FOR LEAD RETENTION). 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 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

    THE PT RECEIVED HIS SCS SYSTEM CONSISTING OF AN IPG, FOUR LEADS AND TWO EXTENSIONS ON (B)(6) 2008. IT WAS REPORTED THAT THE PT HAD LOST STIMULATION AND ONE LEAD HAD HIGH LEAD IMPEDANCE MEASUREMENTS. AN XRAY WAS TAKEN WHICH VERIFIED THAT THE LEAD EXTENSION FOR THAT LEAD HAD COME OUT OF THE IPG HEADER. IT WAS REPORTED THAT THE FIRST ELECTRODE CONTACT FOR THE EXTENSION HAD COME OFF IN THE HEADER AS WELL. THE PHYSICIAN EXPLANTED AND REPLACED THE IPG, LEAD, AND EXTENSION ON (B)(6) 2008. THE EXPLANTED IPG WAS RETURNED TO ANS FOR EVALUATION. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES HAVE BEEN REPORTED.

    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 117155

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention