BEUDAMED
    FDA Adverse Event Other Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 909915 · Received September 7, 2007

    Report

    Report Number
    1627487-2007-00017
    Event Type
    Other
    Date Received
    September 7, 2007
    Date of Event
    August 5, 2007
    Report Date
    September 6, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONALLY, DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED. RESULTS: ALL RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS. ADVANCED NEUROMODULATION SYSTEMS, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO THE RELEVANCE OF THE PATIENT'S HISTORY TO THE EVENT REPORTED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH HIS SYSTEM IN 2007. IT WAS REPORTED THE PATIENT WENT TO THE EMERGENCY ROOM IN 2007, COMPLAINING OF PAIN IN THE IMPLANT POCKET SITE. IT WAS REPORTED THAT THERE WAS AN ABSCESS IN THE PATIENT'S POCKET SITE, AND THE ENTIRE SYSTEM WAS EXPLANTED. FOLLOW UP WITH THE PATIENT FOUND THAT HE HAS RECOVERED FROM THE INFECTION. THE PATIENT WAS IMPLANTED WITH ANOTHER EON IPG AND LEADS, AND IS CURRENTLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IMPLANTABLE PULSE GENERATOR IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC 3716 65333

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other