Model A710 Intellis Clinician Programmer Application, version 2.0.97

FDA Recall #Z-0780-2024 — Class II — December 19, 2023

Recall #Z-0780-2024 Date: December 19, 2023 Classification: Class II Status: Ongoing

Product Description

Reason for Recall

Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief.

Recalling Firm

Medtronic Neuromodulation — Minneapolis, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1 tablet

Distribution

Germany

Code Information

UDI/DI 00763000520076, S/N: NPL1000519

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

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