BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3821628 · Received May 20, 2014

    Report

    Report Number
    1723170-2014-00584
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    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

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. ON (B(4) 2014 A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. NAVIGATION SYSTEM PERFORMED AS INTENDED. SOFTWARE INVESTIGATION COMPLETED. FINDINGS ARE THAT THE MICROSCOPE BRACKET HAS VISIBLE DAMAGE. SOFTWARE IS FUNCTIONING AS DESIGNED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL PROCEDURE, A MICROSCOPE INJECTION WAS ALLEGED TO BE INACCURATE BY APPROXIMATELY 6MM. THE SURGEON WAS ACCURATE WITH OTHER INSTRUMENTATION AND OPTED TO CONTINUE THE SURGERY WITHOUT THE PENTERO SCOPE FOR NAVIGATION. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300568 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 PENTERO MICROSCOPE