BEUDAMED
    FDA Adverse Event Other Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 928587 · Received October 16, 2007

    Report

    Report Number
    1627487-2007-00027
    Event Type
    Other
    Date Received
    October 16, 2007
    Date of Event
    September 11, 2007
    Report Date
    October 16, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES. METHOD: ADDITIONALLY, DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED. RESULTS: ALL RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS. ADVANCED NEUROMODULATION SYSTEMS, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO THE RELEVANCE OF THE PATIENT'S HISTORY TO THE EVENT REPORTED.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED HIS SCS SYSTEM IN 2007. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IPG IMPLANT SITE. THE PATIENT'S SYSTEM WAS EXPLANTED 3 MONTHS LATER. FOLLOW-UP ON THE PATIENT FOUND THAT HE IS HEALING UP FROM THE INFECTION AND SHOULD RECEIVED ANOTHER SCS SYSTEM UPON RECOVERY.

    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 69564

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other