BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3163306 · Received June 11, 2013

    Report

    Report Number
    1723170-2013-00429
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE DECLINED TO PROVIDE PATIENT INFORMATION, REFERENCING (B)(4) PRIVACY LAWS. MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTS THE SYSTEM HAS NOT BEEN MADE AVAILABLE FOR A SYSTEM CHECK-OUT. FILES/LOGS ARE NOT EXPECTED TO BE RETURNED TO MANUFACTURER FOR SOFTWARE EVALUATION. UNABLE TO CONFIRM COMPLAINT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, USING THE O-ARM WITH THE STEALTHSTATION S7, THE SURGEON ALLEGED A 3-4MM INACCURACY. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF NAVIGATION. THERE WAS NO IMPACT ON PATIENT OUTCOME. IT WAS LATER REPORTED THAT THERE WAS ONE SPIN THAT WAS ACCURATE AND ANOTHER THAT SHOWED THE 3-4MM INACCURACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263960 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 O-ARM 1000 IMAGING SYSTEM