FDANovember 12, 2020device

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

medtronic neuromodulationmedtronic

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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