Events

Recall of Medtronic Navigation Framelink (used with Medtronic Navigation StealthStation S7 and i7 systems or a Medtronic Planning Station for image guided surgery) Software version 5.4

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtronic Australasia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-00722-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-07-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00722-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Medtronic has identified that the use of high resolution exams (greater than 256 x 256) under certain use conditions may cause the look-ahead view labels to show user selected depths (displayed), but the corresponding images are shown at a depth twice the selected distance. under these conditions, visualisation of the planned trajectory could show the image at the incorrect depth. further internal investigation of similar or related views discovered that the use of high resolution exams (greater than 256 x 256) under certain use conditions may cause a similar discrepancy between the exam image and the displayed measurement or overlay. the use conditions are;- use of framelink 5.4 software on an s7, i7 or planning station system that has a rollingstone computer, and- the framelink 5.4 software configuration setting "use fillslicestackresolution" is set to true, and- the user loads a high-resolution exam for use during a surgical procedure.
  • Action
    Medtronic is requesting users to not use high-resolution examinations (greater than 256 x 256). A software solution will be implemented to permanently correct the issue.

Device

Medtronic Navigation Framelink (used with Medtronic Navigation StealthStation S7 and i7 systems o...
  • Model / Serial
    Medtronic Navigation Framelink (used with Medtronic Navigation StealthStation S7 and i7 systems or a Medtronic Planning Station for image guided surgery)Software version 5.4Product Number: 9734047All lot numbers of version 5.4 affectedARTG Number: 126293
  • Product Classification
    Neurological Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA