Device product
Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy.
Z-0860-2021
Product summary
- Event
- Event 86872
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7960 downloads
- Official record key
device-enforcement:Z-0860-2021
Official wording
Reason: A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.
Code information: Software version 1.3.80
Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Canada, Latin America, Asia Pacific, Japan, China, and European regions.
Derived failure modes
-
Device software or design
software issue