Events

Recall of EnTrust VR/DR/AT ICDs

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-2018-RN-00833-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-07-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00833-1
  • 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 the potential for loss of high voltage and anti-tachycardia pacing therapy in entrust implantable cardioverter defibrillators (icds) as they near elective replacement indicator (eri) voltage. affected devices may display an immediate “end of life” (eol) observation with no prior alert (implanted electronic heart devices are designed to alert physicians and patients as the device battery depletes). though no elective replacement indicator (eri) alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time eol observation. bradycardia (pacing) therapies will continue to operate as expected. medtronic has received no reports of patient deaths or serious adverse events due to this issue.
  • Action
    Medtronic is advising the below for surgeons following consultation with the Independent Physician Quality Panel: - Schedule an in-office patient follow-up as soon as possible to assess the potential for this issue per the steps outlined in the Customer Letter. - Ensure the Excessive Charge Time EOL…and the Low Battery Voltage ERI… Patient Alerts have been programmed to “On-High”. - Instruct patients to contact your office if they hear device alert tones. Consider utilising the “Demonstrate Tones. . .” function to ensure patients recognise the audible tone. - If this issue has occurred, an “EOL: replace device immediately” Observation will be displayed on the QuickLook report. Schedule device replacement immediately. The Customer Letter provides information for surgeons to ensure high voltage therapy remains as the device battery voltage approaches its 2.61V ERI threshold.

Device

EnTrust VR/DR/AT ICDs

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