Events

Safety Alert for EnTrust implantable cardioverter-defibrillators

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Medtronic.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-03-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20120307.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Press release
  • Reason
    Safety alert over certain medtronic implantable cardioverter-defibrillators the department of health (dh) today (march 6) received notification from a medical device supplier, medtronic international ltd (medtronic), about its voluntary corrective actions concerning some models of entrust and escudo implantable cardioverter-defibrillators (icd). the icds concerned may not meet the expected longevity or provide at least three months of device operation between the elective replacement indicator (eri) and end of life (eol) due to a more-rapid-than-expected drop in battery voltage. according to medtronic, the entrust model numbers affected are d153drg, d153vrc, d153atg, d154vrc, d154drg and d154atg, and escudo d144drg and d144vrc. among the affected models, only entrust d154vrc and d154atg were ever launched in hong kong, but they are no longer marketed here now. medtronic has identified the cause of the problem to be an internal battery short that develops as the battery capacity is consumed. so far, no patient deaths or serious injuries have been reported as a result of this issue. medtronic reported that 51 patients in hong kong have been implanted with the affected models in both private and public hospitals. the manufacturer is in the process of informing the physicians-in-charge of the patients about the problem and the related management recommendations. a dh spokesman advised those patients who have the affected devices implanted should contact their physicians immediately if they feel unwell or have any queries. the department has alerted the hospital authority, private hospitals, relevant institutions and medical associations to the safety alert. while dh has not received any adverse report so far, the department will maintain vigilance and monitor the development of the issue. ends.

Device

EnTrust implantable cardioverter-defibrillators
  • Model / Serial
  • Product Description
    Press release: Safety alert over certain Medtronic implantable cardioverter-defibrillators
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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
    DH