Company: Medtronic Neuromodulation
Date of Enforcement Report: 09/29/2023
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an inability to establish communication with the implanted neurostimulators.
VOLUME OF PRODUCT IN COMMERCE:
Worldwide distribution – US Nationwide (there was government and military distribution) and the countries of Australia and Singapore.