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Recall Observatory FDA recall evidence

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

November 12, 2020

Class II

Product summary

Firm
Medtronic Neuromodulation
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

    reason.device_software_design · v1.0.0

    software issue