Events

Safety Alert for Consulta CRT-D (D234TRK), Secura DR/VR (D234DRG, D234VRC), Maximo II CRT-D (D284TRK) and Maximo II DR/VR (D284DRC, D284VRC)

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
    2010-05-05
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20100506.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
    Software defects cause malfunctioning in medtronic's implantable cardiac devices the department of health (dh) today (may 5) received notification from medtronic international limited (mil), the local branch of a multi-national medical device manufacturer, that software problems in six of its implantable cardiac devices may risk life-threatening though rare malfunctioning. a dh spokesman said, the affected models are consulta crt-d (d234trk), secura dr/vr (d234drg, d234vrc), maximo ii crt-d (d284trk) and maximo ii dr/vr (d284drc, d284vrc). all except maximo ii vr (d284vrc) are distributed in hong kong. as of april 19 this year, the manufacturer has received five confirmed reports of defect out of approximately 144 000 devices sold worldwide. however, it is reassuring that no patient injury or death arising from the affected devices has been reported thus far. here in hong kong, mil's record shows that a total of 40 affected devices have been implanted in patients of either hospital authority or private hospitals. mil recommends no change to current patient management. the devices will receive software updating upon the patients’ next scheduled clinic follow-up. the company is contacting physicians concerned individually. the spokesman does alert patients who have the deficient implants that if they experience cardiac symptoms or hear alerts from the devices, they should seek medical attention immediately. patients can call mil’s hotline at 2919 6413 for further details. meanwhile, the dh has informed both public and private hospitals, and relevant medical associations of the issue, and will also follow up with mil on further development, if any. ends/wednesday, may 5, 2010.

Device

Consulta CRT-D (D234TRK), Secura DR/VR (D234DRG, D234VRC), Maximo II CRT-D (D284TRK) and Maximo I...
  • Model / Serial
  • Product Description
    Press release: Software Defects Cause Malfunctioning in Medtronic's Implantable Cardiac Devices
  • Manufacturer
    Medtronic International Limited

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