BEUDAMED
    FDA Adverse Event Other Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 850192 · Received May 10, 2007

    Report

    Report Number
    1627487-2007-00010
    Event Type
    Other
    Date Received
    May 10, 2007
    Date of Event
    November 30, 2006
    Report Date
    May 10, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    GZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED. RESULTS: ALL RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS. CORP HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. CORP DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S GENERAL PHYSICIAN FOUND THE IPG IMPLANT WOUND SITE HAD ERODED AND HE COULD PLAINLY SEE THE IMPLANTED EON IPG AND LEAD. A SURGEON EXPLANTED THE PT'S IPG AND LEAD, AND A FEW MONTHS LATER THE PT RECEIVED ANOTHER EON IPG AND LEAD. THE PT IS CURRENTLY REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IMPLANTABLE PULSE GENERATOR IMPLANTABLE PULSE GENERATOR GZB ADVANCED NEUROMODULATION SYSTEMS, INC. 3716 47591

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other