Events

Recall of Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM)

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-2016-RN-00202-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00202-1
  • 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 due to the sensitivity of an algorithm used in the reveal linq icm, the recommended replacement time (rrt) alert may be prematurely triggered in some devices. the rrt alert is an indicator for when the reveal linq device should be replaced, therefore the premature alarm indicates replacement before it is necessary. this matter does not impact the ability for the reveal linq device to safely continue collecting data. manual data transmissions may also still continue. device battery capacity is not affected. medtronic has not received any reports of patient complications or injury related to this issue. medtronic has observed an occurrence rate of 0.45% of devices experiencing this issue.
  • Action
    Medtronic is advising clinicians that prophylactic device replacement is not recommended unless the clinician determines the loss of daily wireless transmissions outweighs the potential complications associated with device replacement. If a premature RRT alert is confirmed and EOS status is displayed, options to continue ongoing monitoring include remote manual transmissions or performing an interrogation of the programmer. Medtronic will be providing a software update as a permanent correction. For more information, please see https://www.tga.gov.au/alert/medtronic-reveal-linq-insertable-cardiac-monitor. Thia action has been closed out on 08 Jun 2017

Device

Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM)
  • Model / Serial
    Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM)Model Number: LNQ11ARTG Number: 218791
  • 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