Recall Z-0346-2020 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
LivaNova USA Inc
The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case a
| Date | Nov 16, 2018 |
| Status | Open, Classified |
| Reason | Lead impedance values reported by the affected VNS generator will be higher compared to those reported by previous models. This is due to a change in the timing of when affected VNS generator takes the lead impedance measurement during diagnostic testing. As a result, normal impedance ranges for the affected VNS generator have shifted relative to the existing thresholds of 600 - 5300 Ohms defined in labeling and as present in the programming software. |
| Root cause | Software design |
| Action | On 11/16/18, Medical Device Correction notices were mailed to treating and implanting physicians. The notice informed physicians that as indicated in the Physician's Manual, high lead impedance (greater-than-or-equal-to 5300 Ohms), in the absence of other device-related complications, is not an indication of a lead or generator malfunction. Existing recommendations, as described in the Physician's Manual, should still be followed. This will not impact the performance of the device, including the battery longevity and the ability to safely deliver therapy. The issue presents a risk of unnecess |
| Quantity | 9282 |
| Distribution | US: PA, WV, KY, NY, MD, VA, DC, NC, GA, SC, NJ, DE, MA, OH, RI, CT, ME, NH, VT, IL, WI, IN, MO, MI, MN, SD, ND, NE,KS, IA, TX, OK, TN, MS, AL, FL, LA, ID, MT, WA, OR, UT, AK, AZ, AZ , CO, WY, NM, CA, HI, AR. Foreign (OUS): Austria, Switzerland, Germany, Denmark, Spain, Finland, United Kingdom, Ital |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.