BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3882297 · Received June 18, 2014

    Report

    Report Number
    1723170-2014-00658
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RMA ISSUED. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT CAMERA FINDS THAT, AS RETURNED, THE HOUSING IS DENTED ON THE BACKSIDE CORNER AND ONE EMITTER LENS IS SCRATCHED. THE PSU PASSED AN AAK TEST AT .55 MM WITH HIGH LINE SEPARATION OF 1.86 MM. THE LINE SEPARATION WAS AUTOMATICALLY ADJUSTED BY THE TEST SOFTWARE. THE PSU PASSED A SUBSEQUENT AAK TEST AT .52 MM WITH GOOD LINE SEPARATION OF .09 MM. ALTHOUGH THE PSU PASSED THE ACCURACY TEST, THE READING IS HIGH. ELECTRICAL FAILURE - FAILED DIAGNOSTIC TEST - DIRECTLY CAUSED EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A CAMERA USED FOR RESEARCH & DEVELOPMENT TESTING WITH THE POLESTAR WAS OUT OF CALIBRATION. THIS DEVICE IS FOR INTERNAL TESTING ONLY. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358857 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1