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
Two model 3000 programmers were distributed in error by prior to fda approval of version 1.0.2.2 software.
조치
The units were collected by visit on December 21, 2017 and December 28, 2017 from the physicians. Both programmers have been successfully removed from the customers and no further actions are being proposed.
For further questions, please call (281) 228-7260.
Part Number: 10-0011-0500 Serial number/UDI: 8LYB7F2/010542502575039911170920218LYB7F29910-0011-0500 D80C7F2/01054250257503991117092921D80C7F29910-0011-0500
VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 || Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications. Depression : VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.