BEUDAMED
    FDA Adverse Event Other Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 956406 · Received November 29, 2007

    Report

    Report Number
    1627487-2007-00031
    Event Type
    Other
    Date Received
    November 29, 2007
    Date of Event
    October 29, 2007
    Report Date
    November 29, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD ADDITIONALLY, DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED. RESULTS: ALL RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECS. ANS INC. 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. ANS INC CORP DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH AN EON IPG AND TWO OCTRODE LEADS IN 2006. THE PT REPORTED HAVING SEVERE PAIN IN HIS BACK AND AT THE IPG POCKET SITE ABOUT A YR LATER. THE PHYSICIAN EXPLANTED THE WHOLE SYS IN 2007, AND IMPLANTED ANOTHER EON IPG AND LEADS. ADD'L COMMENTS FROM THE IMPLANTING PHYSICIANS SUGGEST THAT THE REPORTED PAIN WAS RELATED TO THE IMPLANTED DEVICES' LOCATIONS. THERE WAS NO EVIDENCE FOUND THAT THE REPORTED PAIN WAS DEVICE-RELATED. F/U WITH THE PT FOUND HE NO LONGER HAS PAIN IN HIS BACK OR AT THE POCKET SITE.

    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 57687

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other