Recall Z-0535-2021 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
LivaNova USA Inc
VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.
| Date | Nov 12, 2020 |
| Status | Terminated |
| Reason | During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated. |
| Root cause | Device Design |
| Action | On 10/09/2020, the firm hand-delivered an "URGENT: FIELD SAFETY NOTICE" informing its customers that in the event that a generator reset occurs (whether due to troubleshooting efforts or a device issue), the device will erroneously display the incorrect model number as "Model 1000 on the device In-Session programmer screen. The risk to patients could potentially be when the patient undergoes a future generator replacement surgery. Actions Physicians are to take: 1. Model 1000-D devices susceptible to this issue are provided in Attachment 1. When interrogating the generator and performing dia |
| Quantity | 8 generators |
| Distribution | International distribution in the countries of Austria and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.