BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONUS MODERATE SUPPORT GUIDEWIRE

    MDR report key: 661740 · Received January 6, 2006

    Report

    Report Number
    3003778388-2005-00013
    Event Type
    Malfunction
    Date Received
    January 6, 2006
    Date of Event
    November 30, 2005
    Report Date
    December 28, 2005
    Manufacturer
    STEREOTAXIS, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A DR PERFORMED A CARDIAC RESYNCHRONIZATION THERAPY THAT USED ONE CRONUS MODERATE SUPPORT WIRE TO DELIVER A MEDTRONIC LV LEAD SUCCESSFULLY. THIS WAS A MAGNETIC NAVIGATION PROCEDURE THAT USED A CRONUS MODERATE SUPPORT WIRE WHERE THE TIP SHEARED OFF. THE WIRE HAD PROLAPSED PRIOR TO THE SHEARING. BOTH PARTS OF THE WIRE WERE RETURNED. THE TIP WAS IN THE LEAD AND DID NOT STAY IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRONUS MODERATE SUPPORT GUIDEWIRE GUIDEWIRE DQX STEREOTAXIS, INC. 001-001457-1 0509-4178

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN