Events

Recall of Consulta CRT-P (Implantable cardiac pacemaker)

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-00646-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-06-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00646-1
  • 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 recently identified an issue with a subset of consulta® crt-p devices during production. this issue was identified as a result of an internal investigation that indicated a recent trend of increasing manufacturing rejects related to the weld of a connector bracket. an out-of-specification weld could result in a loss of device hermeticity. loss of hermeticity may allow body fluids to enter the device. this has the potential to compromise functionality resulting in loss of output.
  • Action
    Medtronic are asking physicians to advise patients to seek medical attention immediately if they experience a return of symptoms related to bradycardia or heart failure. If considering prophylactic device replacement for pace maker dependant patients with an affected device, physicians should carefully assess individual patient circumstances against the known risk of device replacement. Physicians should continue to routinely follow up patients as per standard practice. For more details, please see http://www.tga.gov.au/safety/alerts-device-consulta-130715.htm .

Device

Consulta CRT-P (Implantable cardiac pacemaker)

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