Recall – Neurostimulator software error results in inability to program device

Company: Medtronic Neuromodulation
Date of Enforcement Report: 1/20/2021
Class II

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.

Recall Number: Z-0860-2021

REASON

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

RECALLING FIRM/MANUFACTURER

Medtronic Neuromodulation on 11/12/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

7960 downloads

DISTRIBUTION

U.S. Nationwide and International

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