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
VNS handheld PCs - Product Code LYJ
원인
During programming, pulse generator may be inadvertently set to 8.0 ma output, regardless of the ma range selected by the clinician.
조치
Firm sent safety alert to physicians on 11/14/06. Safety Alert informs physicians of the problem and provides instructions on how to avoid an event and correct an event should it occur.
For Handheld v6.0: 99-0000-3000; For Handheld v6.1: 10-0006-4300; For Handheld v6.1.7: 10-0007-2700, 10-0007-3600, 10-0007-2609 and 77-0000-7000; For Handheld v7.0: 10-0007-4300; For Handheld v7.1.3: 10-0007-8600.
Worldwide Distribution ---- USA and countries of Argentina, Australia, Austria, Belgium, Canada, Cyprus, Czech Rep, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, S. Korea, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Venezuela.
제품 설명
Handhelds-Cyberonics VNS Therapy System, Model 250-''Handhelds'' preprogrammed with software v6.0, v6.1, v6.1.7, v7.0 and v7.1.3; manufactured by Cyberonics, Inc., Houston, TX.