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
Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
원인
Battery life projection is inaccurate.
조치
Safety Alert sent April 6, 2010 to all physicians of record for Model 103 or Model 104 generators and to all hospitals with non-implanted affected product, that explains the event, risks presented and recommended actions to take. The generator can be reprogrammed by the physician the next time the patient is seen in the clinic.
The issue can also be corrected during the initial implant procedure with the instructions provided.
Additional questions should be directed to the firm; United States customers can contact Clinical Technical Support at 866-882-8804.
VNS Therapy¿ Demipulse¿ Generator, Model 103 and || VNS Therapy Demipulse Duo¿ Generator, Model 104 || VNS Therapy Programming System, Model 250 Version 7.0 and 7.1 Software