Recall Z-0561-2020 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
LivaNova USA Inc
VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
| Date | Dec 20, 2019 (initiated Aug 22, 2019) |
| Status | Terminated |
| Reason | Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devices will continue to be susceptible to resets. If a device experiences this issue, this may lead to additional surgery (premature replacement of generator), or patients may return to baseline seizure frequency or depressive symptoms due to cessation of intended stimulation. |
| Root cause | Device Design |
| Action | On 08/22/19, Urgent Medical Device Correction notices were sent to customers including Neurosurgery, Risk Management, Neurology, and doctors. Doctors were asked to do the following: 1) Monitor the patient frequently and continue to perform diagnostic testing at each visit per labeling. Information and recommendations regarding device checks, resets and monitoring of clinical symptoms can be accessed in the physician's manual. 2) If the initial interrogation of the generator is found to be disabled unexpectedly (0mA output current), contact Customer Quality at (866) 882-8804 (Monday to Friday, |
| Quantity | 1687 |
| Distribution | U.S.: MN, IL, AK, NY, FL, PA, AR, CA, NC, WI, AZ, KY, TX, MA, MT, NE, IA, WV, CO, AL, MI, LA, VA, OH, MO, IN, NJ, GA, TN, MS, DC, SC, CT, UT, OK, MD, ID, KS, DE, OR, ND, WA, NM, PR. OUS (foreign): AT, CH, DE, ES, FI, GB, IE, NL, NO, PT, SE, IT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.