BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIOBE MAGNETIC NAVIGATION SYSTEM

    MDR report key: 756363 · Received August 28, 2006

    Report

    Report Number
    3003084417-2006-00001
    Event Type
    Injury
    Date Received
    August 28, 2006
    Date of Event
    August 15, 2006
    Report Date
    August 28, 2006
    Manufacturer
    STEREOTAXIS, INC.
    Product Code
    MQB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE NIOBE SYSTEM IS NOT AN INVASIVE PRODUCT AND PERFORMED AS INTENDED. THE ADVERSE EVENT THAT OCCURRED MAY HAVE BEEN CAUSED BY ANOTHER PRODUCT USED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    MALE PATIENT (AGE NOT KNOWN AT THIS TIME) PRESENTED TO THE USCF MEDICAL CENTER WITH A 7 YEAR HISTORY OF ATRIAL FIBRILLATION (AF). PATIENT'S LEFT ATRIUM WAS 6 CM AT THE TIME OF PRESENTATION. PATIENT UNDERWENT MAPPING AND ABLATION PROCEDURE FOR CHRONIC ATRIAL FIBRILLATION (GENERATOR SETTINGS: 30 W, 50 DEGREES-55 DEGREES C) AND SUFFERED A CEREBROVASCULAR ACCIDENT DURING THE PERIOPERATIVE PERIOD (EXACT TIME & DATE UNKNOWN). THIS STROKE WAS CONFIRMED BY MRI AND DID SUBSEQUENTLY RESOLVE WITHOUT SEQUELAE. SITE NOTES THAT THERE WAS COAGULUM PRESENT ON THE CATHETER TIP. INCIDENT WAS COMMUNICATED TO STEREOTAXIS EMPLOYEE IN 2006 BY REPORTER. THIS REPORT WAS FORWARDED TO BIOSENSE-WEBATER, INC. A NAVISTAR RMT 4MM CATHETER WAS IN USE DURING THE ABLATION. THIS PROCEDURE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIOBE MAGNETIC NAVIGATION SYSTEM STEERABLE CATHETER CONTROL SYSTEM MQB STEREOTAXIS, INC. 001-006100-1 0140

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| L| R BIOSENSE WEBSTER, INC. NAVISTAR RMT 4MM CATHETER