Events

Recall of Medtronic Amplia CRT-D Surescan

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Medtronic Inc.

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
    20927
  • Event Initiated Date
    2016-12-08
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
  • Reason
    Phase 1: manufacturer has identified a device software issue that may occur with all models of claria mri crt-d surescan and amplia mri crt-d surescan devices. the issue is a loss of lv pacing that occurs following a specific device programming sequence. as of november 10 , 2016, the manufacturer has observed an overall occurrence rate of 0.38%. but all tachyarrhythmia detection and therapy features remain fully operational. the software issue can be corrected by re-programming the device., the manufacturerwill also address an unrelated transient mode switch behaviour that may occur in mri quadripolar crt-d device models (claria mri™, amplia mri™ and compia mri™)., phase 2: a software update is being developed to address this issue and will be communicated to clinicians once it becomes available, the updated software (sw034 software version 8.2) is now available to correct the issue 1 in the affected claria mri and amplia mri crt-d surescan devices.
  • Action
    Software to be upgraded

Device

Medtronic Amplia CRT-D Surescan
  • Model / Serial
    Model: DTMB2D4, Affected:
  • Manufacturer
    Medtronic Inc

Manufacturer

Medtronic Inc
  • 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
    NZMMDSA