Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis P

FDA device recall Z-1543-2025 · posted 2025-04-08 · Open, Classified

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.

Action taken

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 potential of this issue and the steps to mitigate it. Ensure that backup INS devices are readily available for scheduled surgeries. During the implant procedure, check the system integrity before securing the neurostimulator in place as described in the Inceptiv/Intellis Pro Implant Manual. Please complete and return the customer confirmation form enclosed in this letter acknowledging that you have received this information. Please contact Medtronic Technical Services at 1-800-707-0933 if you have any questions regarding this communication.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LGW

Quantity affected

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, Hungar

Date initiated

2025-03-04

Date posted

2025-04-08

Location

Minneapolis, MN