Events

Recall of Amplia MRI CRT-D SureScan and Claria MRI CRT-D SureScan Amplia MRI CRT-D SureScan/Amplia MRI Quad CRT-D

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-01604-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-12-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01604-1
  • 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 is writing to inform physicians about a software issue that could result in the loss of lv pacing that occurs following a specific device programming sequence. if it occurs, this issue can be corrected by re-programming the device. all tachyarrhythmia detection and therapy features remain fully operational. the issue can only occur in devices that have been programmed from managed ventricular pacing (mvp) mode to a pacing mode with adaptivcrt enabled. when a patient with adaptivcrt enabled (shipped setting) is subsequently programmed to mvp mode and then re-programmed back to ddd or dddr, adaptivcrt is not re-enabled. when this programming sequence occurs, lv pacing is not delivered, despite parameters indicating adaptivcrt is enabled. through 10 november 2016, two events have been reported to medtronic related to this issue. a review of the data revealed an overall occurrence rate of 0.38%. medtronic has not received any reports of patient injury related to this issue.
  • Action
    A software update is being developed by Medtronic to address this issue in Claria MRI and Amplia MRI devices. This software update will also address an unrelated transient mode switch behaviour in all Quadripolar models of Claria MRI, Amplia MRI, and Compia MRI CRT-D SureScan devices. Further information will be communicated once the software update receives applicable regulatory approvals. Until the software update has been approved and the affected models receive the update, Physicians are advised to follow the programming recommendations in the customer letter. These recommendations also apply to any new device implants.

Device

Amplia MRI CRT-D SureScan and Claria MRI CRT-D SureScan Amplia MRI CRT-D SureScan/Amplia MRI Quad...
  • Model / Serial
    Amplia MRI CRT-D SureScan and Claria MRI CRT-D SureScan Amplia MRI CRT-D SureScan/Amplia MRI Quad CRT-D SureScanModels: DTMB2D1, DTMB2D4, DTMB2QQClaria MRI CRT-D SureScan/ Claria MRI Quad CRT-D SureScan Models: DTMA2D1, DTMA2D4, DTMA2Q1, DTMA2QQMultiple ARTG numbers
  • Product Classification
    Cardiovascular 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