BEUDAMED
    FDA Adverse Event Other Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 922814 · Received October 3, 2007

    Report

    Report Number
    1627487-2007-00025
    Event Type
    Other
    Date Received
    October 3, 2007
    Date of Event
    August 31, 2007
    Report Date
    October 3, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS IMPLANTED WITH AN EON IPG AND A LEAD IN 2007 AS A REVISION TO A PRIOR SCS SYSTEM SHE HAD RECEIVED. IN THE RECOVERY ROOM, THE PATIENT WAS REPORTED AS PARALYZED AND NUMB FROM THE CHEST DOWN. THE PATIENT'S SYSTEM WAS EXPLANTED, AND THE PHYSICIAN PERFORMED A LAMINECTOMY AT T7-8 FOR DECOMPRESSION. THE PATIENT WAS DISCHARGED WITH REPORTEDLY STILL SOME NUMBNESS AND A DEFICIT IN MOVEMENT IN HER FOOT. THE PATIENT LATER RECEIVED ANOTHER LAMINECTOMY AT T9-T11. FOLLOW UP WITH THE PATIENT FOUND THAT MOST SENSORY AND MOTOR FUNCTION HAS RETURNED.

    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 83990

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other