FDA-Device2021-01-20Class II

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.

Medtronic Neuromodulation
Hazard

A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.

Sold states
Worldwide distribution - US Nationwide distribution and the countries of Canada, Latin America, Asia Pacific, Japan, China, and European regions.
Affected count
7960 downloads
Manufactured in
7000 Central Ave Ne, N/A, Minneapolis, MN, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0860-2021

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