PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: January 20, 2021 Initiated: November 12, 2020 #Z-0860-2021

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Medtronic Neuromodulation
Units Affected
7960 downloads
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Canada, Latin America, Asia Pacific, Japan, China, and European regions.
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Medtronic Neuromodulation. Units affected: 7960 downloads.
Why was this product recalled?
A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 20, 2021. Severity: Moderate. Recall number: Z-0860-2021.