BEUDAMED
    FDA Adverse Event Other Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1031782 · Received April 17, 2008

    Report

    Report Number
    1627487-2008-00006
    Event Type
    Other
    Date Received
    April 17, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 17, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH AN EON IPG AND LEADS FOR SCS IN 2008. IN THE SAME MONTH, THE PT REPORTED FEELING A BURNING SENSATION IN HER IPG POCKET SITE. THE FOLLOWING MONTH, THE PATIENT'S SYSTEM WAS EXPLANTED DUE TO AN INFECTION AT THE MIDLINE INCISION. THE EXPLANTED PRODUCTS WERE DISCARDED BY THE HOSPITAL AND WERE NOT RETURNED TO ANS FOR EVAL. FOLLOW-UP WITH THE PT FOUND THAT SHE IS RECOVERING WELL 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 113725

    Patients

    Seq Age Sex Outcome Treatment
    1 Other