Recall Z-2255-2018 ยท MUZ Stimulator, Autonomic Nerve, Implanted (Depression)
Cyberonics, Inc
VNS Therapy Programmer, Model 3000, v1.0 System
| Date | Nov 13, 2017 |
| Status | Terminated |
| Reason | Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators. During these programming events, the miscalculations can lead to: " Delivery of more stimulation than intended, resulting in painful stimulation or other common side effects (Model 106 only); " No stimulation in the case of device disablement (Burst Watchdog Timeout), resulting in no therapy to the patient (Model 106 only); " Delivery of less stimulation than intended, resulting in therapeutic settings not being achieved within device specification (Mod |
| Root cause | Device Design |
| Action | On November 13, 2017 LivaNva sent letters to all the doctor and surgeons that use this device. "Dear Doctor: This notification describes an issue identified with the VNS Therapy Programmer, Model 3000 version 1.0 which may impact patients implanted with Models 103, 104, 105 or 106 VNS Therapy generators. This issue does not affect Model 1000 SenTiva or Model 102/102R generators. What is the Issue? Certain programming events performed with a Model 3000 Programmer on a Model 103, 104, 105 or 106 VNS Therapy generator can result in a miscalculation of some parameters stored in the generator, wh |
| Quantity | 252 |
| Distribution | AL, CA, CO, DE, FL, GA, ID, IL, IN, ME, MO, MS, NC, NJ, NY, PA, TN, TN, TX, UT, WA and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.