BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON 16-CHANNEL IPG

    MDR report key: 1163809 · Received September 17, 2008

    Report

    Report Number
    1627487-2008-00029
    Event Type
    Injury
    Date Received
    September 17, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL FOR DEVICE 2 OF 2 (REFER TO MANUFACTURER'S REPORT NUMBER 1627487-2008-00028 FOR DEVICE 1). METHOD: DEVICE HISTORY RECORD AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: ALL RECORDS REVIEWED 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

    DEVICE 2 OF 2 (REFER TO MANUFACTURER'S REPORT NUMBER 1627487-2008-00028 FOR DEVICE 1). IN 2008, PT WAS IMPLANTED WITH A LEAD AT T9-T10 IPG FOR BILATERAL LEG AND FOOT PAIN. IT WAS REPORTED POST-OPERATIVE THE PT WAS FINE AND THAT THE PT STIMULATOR WAS TURNED ON THE FOLLOWING DAY IN THE HOSPITAL, AND PT RECEIVED GOOD STIMULATION. IT WAS REPORTED THAT AT THE POST-OPERATIVE PROGRAMMING THE FOLLOWING WEEK, THAT THE PT WAS DOING WELL. AT APPROXIMATELY 14 DAYS POST-OPERATION, PT CONTACTED TECHNICAL SUPPORT AND REPORTED SHE COULD NOT FEEL OR MOVE HER LEGS. PATIENT'S PHYSICIAN WAS CONTACTED, WHO INSTRUCTED PT TO GO TO THE EMERGENCY ROOM. IT WAS REPORTED IN THE NEXT DAY, THAT THE ON-CALL NEURO AT THE ER TOOK PT INTO OPERATING ROOM, FOUND, AND REMOVED A HEMATOMA. THE SYSTEM WAS NOT RETURNED TO ANS FOR EVAL. FOLLOW-UP ON THE PT FOUND THE PT HAD NOT REGAINED MOVEMENT/FEELING BELOW THE WAIST. A FOLLOW-UP REPORT WILL BE PROVIDED WHEN ANS RECEIVED FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16-CHANNEL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS INC. 3716 119940

    Patients

    Seq Age Sex Outcome Treatment
    1 Other