Events

Safety Alert for Sprint Fidelis family of implantable defibrillation leads

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

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
    2007-10-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20071015.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
    Voluntary suspension of defibrillation leads the department of health (dh) today (october 15) received a notification from a medical device manufacturing company concerning its decision to voluntarily suspend the worldwide distribution of four models of implantable defibrillation leads (components of a device to regulate a patient's heartbeat) due to the potential for lead fractures. the notification from medtronic international ltd involved the sprint fidelis family of implantable defibrillation leads. the four models are 6930, 6931, 6948 and 6949. according to the company, over 200 such leads have been distributed to hong kong . so far, dh has not received any report of death or injury in hong kong associated with the devices. dh will closely monitor the development. dh has alerted the hospital authority, the private hospitals and the medical professional institutions of the notification and advised them to check with the supplier. according to the company, lead fractures may present as audible alerts, inappropriate shocks and/or loss of output. individual patients who think they may have been implanted with the devices in question should contact their attending doctors. doctors are advised to immediately stop implanting the devices and contact the company for more information on how to follow-up with patients who have implanted with the leads concerned. the manufacturer did not recommend immediate replacement of the leads in all patients except in very unusual circumstances. patients may call the medtronic international ltd's hotline at 2907 5911 from 9:00 am to 5:30 pm on monday to friday for details about the notification. ends/monday, october 15, 2007.

Device

Sprint Fidelis family of implantable defibrillation leads

Manufacturer

Medtronic International 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
    DH