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
The recalled product was distributed with an incorrect serial number printed on the device's label.
조치
The recalling firm visited the one consignee on 11/4/2014 to inform the consignee of the recall and arrange for the return of the recalled devices.
Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. || Indicated for use as an adjunctive therapy in reducing the frequency of seizures.