BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1790833 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01662
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    December 8, 2005
    Report Date
    August 6, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE IPG PASSED ALL FUNCTIONAL TESTING. THE IPG WAS RETURNED WITH LEAD SEGMENTS STILL IN THE HEADER, BUT THEY WERE NOT SEATED ALL THE WAY IN. IT IS UNKNOWN IF THIS OCCURRED DURING EXPLANT OR IF THEY WERE SEATED THIS WAY WHILE IMPLANTED AND CAUSED INTERMITTENT STIMULATION. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO AN FDA INSPECTION. A RETROSPECTIVE REVIEW OF THE COMPLAINT RECORD DETERMINED THAT ANS MISINTERPRETED THE MDR REGULATIONS IN THIS INSTANCE. 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 HER SCS SYSTEM CONSISTING OF AN IPG AND 2 PERCUTANEOUS LEADS ON (B)(6) 2005. ON (B)(6) 2005, IT WAS REPORTED THAT THE PATIENT LOST STIMULATION. SHE TRIED TO FULLY RECHARGE THE IPG BUT THIS DID NOT RESOLVE THE ISSUE. THE IPG WAS EXPLANTED AND RETURNED TO ANS FOR ANALYSIS. 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 R3816A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention