Recall Z-1543-2025 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Medtronic Neuromodulation
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
| Date | Apr 8, 2025 (initiated Mar 4, 2025) |
| Status | Open, Classified |
| Reason | There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used. |
| Root cause | Under Investigation by firm |
| Action | An "URGENT: MEDICAL DEVICE CORRECTION" notification letter dated March 2025 was sent to customers. The letter described the product, problem and actions to be taken. Required Actions: When utilizing any of the lead options mentioned above, avoid using the Switch Device feature to transfer data from the Model A71300 Stimulation Trialing CP App to the Model A71400 Stimulation RC CP App. As an alternative, manually enter the patient and lead information using the Model A71400 Stimulation RC CP App, ensuring not to utilize the Switch Device feature. Inform relevant medical staff about the potenti |
| Quantity | 1493 devices |
| Distribution | Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Austria, Belgium, Bulgaria, Canary Islands, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Luxembourg, Malta, Netherlands, Northern Ireland, Norway, Poland, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.