| Reason for the Action |
Medtronic has released software version 2.1.4148 of the Vanta Clinician Programmer Application (CPA), Model A71200. This software version, and later versions, includes a firmware update to mitigate the previously communicated Market Actions, Vanta Implantable Neurostimulator (INS) Failure After Cardioversion and Vanta Model 977006 Unable to be Interrogated (TGA References RC-2023-RN-00513-1 and RC-2022-RN-00837-1).
Cardioversion procedures may damage the electronics of the Vanta Model 977006 implantable neurostimulator (INS), potentially rendering the device unresponsive and nonfunctional. Surgical replacement may be required to restore stimulation therapy. To reduce this risk, Medtronic identified programming mitigations and updated the applicable labelling to include recommended device settings and programming considerations for cardioversion procedures.
The Vanta Model 977006 implantable neurostimulator (INS) may experience a communication problem that prevents the clinician programmer and/or patient programmer from interrogating or connecting to the device. Although the INS continues to deliver therapy according to the programmed parameters, loss of communication may prevent therapy adjustments and result in inadequate therapy.
If communication cannot be restored, troubleshooting may delay an implant procedure, or an unanticipated surgical intervention may be required to replace the INS. |