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
nerve stimulator - Product Code LYJ
원인
Some vns therapy system replacement demipulse generators reporting low lead impedance readings. in rare instances, a system diagnostic test using model 250 programming software (versions 7.1 and earlier) may report "lead impedance: ok" when a short-circuit condition exists.
조치
Cyberonics sent an Important Safety Notice on July 24, 2009, to all physicians explaining the event, risks presented and recommended actions to take. Labeling updates are being developed concurrently with the notification. The firm will mail or hand-deliver the notifications via firm representatives.
Worldwide: USA, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Poland, Portugal, Puerto Rico (US Territory), Russia, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
제품 설명
Cyberonics VNS Therapy Programming M250 Programming System, model number 250, version 4.6, 6.1, 7.0 and 7.1. The Model 250 Handheld software is provided on flashcards packaged in software envelopes or pre-installed on handheld computers.