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
Certain model 106 pulse generators demonstrate delays in sensing during use of the 'verify heartbeat detection' feature and exhibit the potential for decreased battery longevity.
조치
Cyberonics sent out written recall notification beginning October 14, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For further questions, please call 866-882-8804