Events

Safety Alert for Medtronic Cardiac Resynchronization Therapy and 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
    2018-02-28
  • Event Date Posted
    2018-02-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180228b.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
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: medtronic cardiac resynchronization therapy and implantable cardioverter defibrillators the united states food and drug administration (fda) has issued an alert concerning cardiac resynchronization therapy with defibrillation (crt-ds) and implantable cardiovert-defibrillators (icds), manufacturer by medtronic. the affected products are identified as follows: product codes: nik, lws serial numbers: refer to the fda website. manufactured from 13 july 2013 to 8 august 2017. the manufacturer is recalling certain icds and crt-ds due to a defect in the manufacturing process. this defect causes an out of specification gas mixture inside the device and may prevent the device from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest. according to the manufacturer, the delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient’s heart whose heartbeat is too slow could result in serious injury and/or death. the affected customers are asked to take to following actions: consider prophylactic device replacement for patients who have been implanted with one of the affected devices. contact their medtronic sales representative for terms and conditions for device warranties. review the recall notice and ensure appropriate staff is aware of the notice. the manufacturer will offer a supplemental device warranty for affected devices. for details, please refer to the fda website: https://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm598198.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 february 2018.

Device

Medtronic Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators

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