BEUDAMED
    FDA Adverse Event Other Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 922816 · Received October 3, 2007

    Report

    Report Number
    1627487-2007-00022
    Event Type
    Other
    Date Received
    October 3, 2007
    Date of Event
    August 27, 2007
    Report Date
    October 3, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 2. H6: METHOD: DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE ALSO REVIEWED. RESULTS: ALL RECORDS 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

    THE PATIENT RECEIVED AN EON IPG AND LAMITRODE LEAD ON (B)(6) 2007. THIS SYSTEM WAS EXPLANTED ON (B)(6) 2007 AFTER THE PATIENT DEVELOPED AN INFECTION. FOLLOW-UP WITH THE PATIENT FOUND THAT SHE IS RECOVERING FROM THE INFECTION. SHE HAS NOT YET RECEIVED HER NEW SCS SYSTEM.

    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 67524

    Patients

    Seq Age Sex Outcome Treatment
    1 Other