Events

Recall of Model 5392 Dual-Chamber External Pulse Generator

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-2015-RN-00257-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-03-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00257-1
  • 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 received reports where the negative terminal of a commercially available aa (lr6) battery did not maintain a sufficient connection with the battery drawer electrical contact. this issue could prevent the epg from powering on or cause the epg to abruptly lose primary battery power, potentially stopping delivery of pacing therapy.
  • Action
    Medtronic is working with hospitals to develop a correction plan. The scheduling of the correction is dependent on the availability of loan devices. In the interim hospitals have been advised to ensure that compatible batteries are used. Medtronic will assist end users in determining compatibility. This action has been closed-out on 1/06/2016.

Device

Model 5392 Dual-Chamber External Pulse Generator
  • Model / Serial
    Model 5392 Dual-Chamber External Pulse GeneratorSerial Numbers equal or lower than DJH009999PARTG Number: 128599
  • 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