Device product
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.
Z-0555-2018
Product summary
- Firm
- Cyberonics, Inc
- Event
- Event 78914
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-0555-2018
Official wording
Reason: Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.
Code information: Part Number: 10-0011-0500 Serial number/UDI: 8LYB7F2/010542502575039911170920218LYB7F29910-0011-0500 D80C7F2/01054250257503991117092921D80C7F29910-0011-0500
Distribution pattern: US Distribution to the states of : CO and ND
Derived failure modes
-
Device software or design
error by prior to FDA approval of version 1.0.2.2 software