BEUDAMED
    FDA Adverse Event Other Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 948520 · Received November 9, 2007

    Report

    Report Number
    1627487-2007-00029
    Event Type
    Other
    Date Received
    November 9, 2007
    Date of Event
    October 10, 2007
    Report Date
    November 12, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 2. EVALUATION - METHOD: ADDITIONALLY, DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED. RESULTS: ALL RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS. ANS INC. CORPORATION HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS INC. CORPORATION DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED HIS SCS SYSTEM CONSISTING OF AN EON IPG AND A LAMITRODE LEAD IN 2007. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND HIS SYSTEM WAS EXPLANTED ABOUT 2 WEEKS AFTER. FOLLOW-UP ON THE PATIENT FOUND THAT HE IS RECOVERING FROM THE INFECTION.

    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 83268

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other