Recall Z-1591-2010 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Cyberonics, Inc
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
| Date | May 10, 2010 (initiated Apr 6, 2010) |
| Status | Terminated |
| Reason | Battery life projection is inaccurate. |
| Root cause | Software design |
| Action | 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. |
| Quantity | Model103: 8109 units; Model 104: 1722 units; Programmers: 8891 |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.