BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 1963443 · Received December 20, 2010

    Report

    Report Number
    1723170-2010-00203
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED AN INACCURACY OF 4MM LATERALLY AND POSTERIOR 30 MINS INTO AN (B)(4) CASE. THE SURGEON CONTINUED THE SURGERY USING THE SYSTEM WITH NO IMPACT ON THE PT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR