Recall Z-1563-2020 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
LivaNova USA Inc
VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.
| Date | Feb 4, 2020 |
| Status | Open, Classified |
| Reason | False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-session re-interrogation performed. Users instructed to lower output current and widen pulse width. Only system diagnostic testing evaluates output current. Users may conclude device malfunction, could lead to medical/surgical intervention. |
| Root cause | Software Design Change |
| Action | On 02/04/20, Urgent Medical Device Correction notices were mailed to Doctors, who were informed the following: Which Patients are Potentially Impacted? Because the false positive warning message only appears if the generator is initially interrogated at 0mA, there are only certain scenarios where the issue may appear: - After initial implant, when the device is programmed on for the first time; - Following an MRI, after the device was programmed to 0mA per labeling instructions; or - Resuming therapy following previous device disablement due to an adverse event or device issue. Actions to be |
| Quantity | 2683 |
| Distribution | U.S.: LA, ID, AZ, UT, KY, VA, TN, NY, SC, IL, IN, NC, WA, CA, OH, FL, PA, NJ, CO, TX, RI, MD, HI, OR, MA, NE, MO, OK, MS, MN, SD, VT, AR, WV, WI, MI, AL, KS, DE, NM, GA, ND, AK, MT, ME, NV, DC, MO, WY, IA, CT. Canada, and Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.