BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2152176 · Received June 23, 2011

    Report

    Report Number
    1723170-2011-01139
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SOFTWARE FINDINGS STILL UNDER INVESTIGATION. MEDTRONIC REPRESENTATIVE TOOK POLESTAR LOG FILES FOR FURTHER TROUBLESHOOTING.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED DURING A CASE THE SURGEON COULDN'T VERIFY THE PROBE. AFTER REMOVING ONE SPHERE GEOMETRY ERROR DROPPED DOWN AND THE SURGEON VERIFIED THE PROBE. TROUBLESHOOTING AFTER SURGERY REVEALED THAT THE SPHERES WERE PROBABLY DIRTY. CHANGING THEM TO THE NEW ONES SOLVED THE ISSUE. WHILE NAVIGATING WITH ORIGINAL SPHERES DURING CASE, THE SURGEON NOTICED INACCURACY DURING NAVIGATION ON POLESTAR IMAGES. NAVIGATION ON THE LAST POLESTAR SCAN DONE ON THE SKIN AND BONE LANDMARKS SEEMED TO BE ACCURATE. AFTER COMPLETION OF THE SURGERY, HEART MASSAGE WAS REQUIRED. THE SURGEON STATED RESUSCITATION WENT WELL, BREATHING AND BLOOD CIRCULATION RETURNED. THE PT DIED ON FRIDAY (B)(6) 2011 FROM RIGHT VENTRICLE SEVERE INSUFFICIENCY, DEATH NOT RELATED TO MEDTRONIC PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION S7 SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. S7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death