BEUDAMED
    FDA Adverse Event Other Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 806448 · Received January 4, 2007

    Report

    Report Number
    1627487-2006-00003
    Event Type
    Other
    Date Received
    January 4, 2007
    Date of Event
    November 27, 2006
    Report Date
    January 4, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: DEVICE HAS BEEN REC'D AT ANS AND IS CURRENTLY BEING EVALUATED. ANS, INC. CORPORATION 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. ANS, INC. CORP. DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED IN 2006 WITH TWO LEADS AND AN EON IPG. THE LEAD IMPLANT SITE REPORTABLY BECAME INFECTED AND THE PHYSICIAN REMOVED THE LEADS. SIX MONTHS LATER THE PHYSICIAN REMOVED THE IPG BUT THEN DECIDED NOT TO IMPLANT A NEW SCS SYSTEM DUE TO PT'S HIGH INFECTION RISK. THE PHYSICIAN STATED HE DID NOT FEEL THE INFECTION WAS DEVICE-RELATED. FOLLOW-UP ON THE PT FOUND THAT HE HAS RECOVERED 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 50117

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other