BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATON S7 SYSTEM

    MDR report key: 2150585 · Received June 22, 2011

    Report

    Report Number
    1723170-2011-01138
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS A USABILITY COMPLAINT. MEDTRONIC REPRESENTATIVE INVESTIGATION FINDS EVERYTHING CHECKED OUT CORRECTLY. PERFORMED NAVIGATED SPIN WITH SAWBONES AND NAVLOCK, WERE ALL ACCURATE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SITE EXPERIENCED A PROBLEM WITH GRAY NAVLOCK BEHAVIOR IN SYNERGY 2.0/ROLLINGSTONE. TO USE THE GRAY NAVLOCK, WITH TAP ADDED, YOU MUST ZOOM OUT TO SEE THE TAP, OTHERWISE IT IS OFF THE SCREEN. THE SURGEON COMPLETED THE SURGERY WITH THE USE OF THE STEALTHSTATION S7. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR