BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 1922600 · Received November 19, 2010

    Report

    Report Number
    1723170-2010-00091
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    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

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT DURING AN ENT CASE, THE SURGEON WAS UNABLE TO TRACK PT REFERENCE FRAME OR INSTRUMENTS. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK