BEUDAMED
    FDA Adverse Event Other Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 959776 · Received December 4, 2007

    Report

    Report Number
    1627487-2007-00033
    Event Type
    Other
    Date Received
    December 4, 2007
    Date of Event
    October 3, 2007
    Report Date
    December 4, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 SPECIFICATIONS. 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

    THE PT WAS IMPLANTED WITH AN EON IPG AND A LEAD IN 2007. THE PT REPORTED HAVING CHEST PAIN AND THE NEXT MONTH, THE ENTIRE SYSTEM WAS EXPLANTED. THE PT WAS NOT REIMPLANTED. ADDITIONAL COMMENTS FROM THE IMPLANTING PHYSICIAN SUGGESTS THAT, THE CAUSE OF THE REPORTED PAIN MAY BE DUE TO THE LOCATION OF THE IMPLANTED LEAD AND NOT DEVICE-RELATED. UPON DEVICE EVAL, THERE WAS NO EVIDENCE FOUND THAT THE REPORTED PAIN WAS RELATED TO THE FUNCTION OF THE DEVICE.

    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 85045

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Other