U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Detector and alarm, arrhythmia - Product Code DSI
원인
Medtronic has identified an issue with the sensitivity of an algorithm used in the reveal linq icm that may prematurely trigger the recommended replacement time (rrt) alert in some devices. battery capacity is not affected and the device will continue to support data collection and manual data transmissions. as part of the normal behavior of the device, 30 days after rrt status is reached, reveal.
조치
Consignees in US were hand delivered a Medtronic "Medical Device Correction" letter dated February 2016. The letter was addressed to Physician or Healthcare Professional. The letter described the Issue & Patient Management Guidance. For questions contact your local Medtronic Representative or Medtronic Diagnostic Technical Services at 800-929-4043.
Outside the U.S., the letter will be mailed or hand delivered to impacted consignees.
Worldwide Distribution-US (nationwide) including DC and the countries of Andorra, Australia, Austria, Belgium, Botswana, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Faroe Islands , Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Namibia, Netherlands, New Caledonia, New Zealand, Norway, Oman, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania, Thailand, Turkey, United Arab Emirates and United Kingdom.
“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.