BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 6195275 · Received December 21, 2016

    Report

    Report Number
    1723170-2016-05879
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 21, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE REPRESENTATIVE REPORTED THAT AFTER CALIBRATION OF THE SYSTEM THAT THE REGISTRATIONS WERE WITHIN SPECIFICATIONS FOR ACCURACY.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL RESECTION, THE SURGEON FELT INACCURATE WHEN USING THE NAVIGATION SYSTEM ALONGSIDE A MICROSCOPE. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846090 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1