Events

Safety Alert for EnTrust VR/DRI AT 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
    2018-06-28
  • Event Date Posted
    2018-06-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180628b.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 entrust vr/dri at implantable cardioverter defibrillators medical device manufacturer, medtronic, has issued a medical device safety alert concerning its entrust vr/dri at (icds) [model: d154atg, d154vrc]. the manufacturer has identified of the potential for loss of high voltage and anti-tachycardia pacing therapy in the affected products as they near elective replacement indicator (eri) voltage. according to the manufacturer, under certain circumstances, the device may display an immediate end of life (eol) observation with no prior eri alert. though no eri alert is triggered there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time eol observation, leading to a loss of high voltage and anti-tachycardia pacing therapy. bradycardia therapies will continue to operate as expected. through 15 jun 2018, the manufacturer has confirmed 25 charge timeout events related to the issue, with no patient deaths or complications. time from implant to the devices experiencing the issue is ranging from 7.9-11.7 years. the affected users are recommended to take the following actions: consider scheduling an in-office patient follow-up as soon as possible to assess the potential for the issue. ensure the “excessive charge time eol...And the low battery voltage eri ...” patient alerts have been programmed to "on-high" instruct patients to contact manufacturer if they hear device alert tones. consider utilizing the "demonstrate tones...” function to ensure patients recognize the audible tone. if the issue has occurred, an "eol: replace device immediately" observation will be displayed on the quicklook report. schedule a device replacement immediately. additionally, the manufacturer recommends the actions to help ensure patient safety and effective high voltage therapy remain as the device battery voltage approaches its 2.61v eri threshold the manufacturer will offer a supplemental device warranty for prophylactic replacements as defined under the patient management recommendations. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 june 2018.

Device

EnTrust VR/DRI AT Implantable Cardioverter Defibrillators
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic EnTrust VR/DRI AT 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