BEUDAMED
    FDA Adverse Event Other Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1025508 · Received April 4, 2008

    Report

    Report Number
    1627487-2008-00005
    Event Type
    Other
    Date Received
    April 4, 2008
    Date of Event
    February 22, 2008
    Report Date
    April 4, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONALLY, DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED. ALL RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECS. ANS INC HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. ANS INC DEFERS TO THE PT'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. IT WAS REPORTED THAT DURING IMPLANTATION ONE OF THE LEADS WAS INADVERTENTLY DAMAGED. PRIOR TO REVISING THIS LEAD EIGHT DAYS LATER, THE SURGEON NOTICED THAT THE PT'S IPG POCKET WAS OOZING. THE SURGEON THOUGHT THE IPG POCKET WAS INFECTED AND EXPLANTED THE IPG. F/U ON THE PT FOUND THAT SHE 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 113540

    Patients

    Seq Age Sex Outcome Treatment
    1 Other