Events

Safety Alert for Concerto CRT-D and Virtuoso ICD

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

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
    2009-09-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20090909.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
    Heartbeat regulating products with low-voltage problem the department of health (dh) received notification from a medical device manufacturing company about possible battery life-related problem of certain devices used for regulating heartbeats, including implantable cardiac defibrillators (icds) and cardiac resynchronization therapy defibrillators (crt-ds). a dh spokesman said, the notification from medtronic international limited involved the products, a subset of concerto crt-d and a subset of virtuoso icd. it was found that the problem is due to a low-voltage capacitor which may be subject to degradation, causing accelerated depletion of the batteries in the affected products. so far 230 of approximately 6,300 devices overseas have been confirmed to have accelerated battery depletion. according to the company, there have not been any report ed deaths or serious injuries resulting from the problem, both overseas and locally. according to the medtronic international limited, in hong kong , three devices have been implanted in hospitals under hospital authority (ha). medtronic has contacted ha and related doctors to advise them how to address the problem . the spokesman said, individual patients implanted with affected devices should follow their scheduled appointments for follow up. however, they should contact their attending doctors immediately if receive an alert tone coming from their implanted device . patients may call medtronic international limited's hotline at 2919 6413 for further details about the notification . the dh has informed public and private hospitals, and medical professional associations about this notification and advise d them to take necessary follow up actions. ends/tuesday, september 8, 2009.

Device

Concerto CRT-D and Virtuoso ICD

Manufacturer

Medtronic International Limited
  • 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