Medtronic Neuromodulation recalls The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation o…

Recall date

January 9, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1147-2015

FDA classification

Class II

Brand / firm

Medtronic Neuromodulation

Sold / distributed

Worldwide Distributon- USA( nationwide including DC and PR) and Internationally to Mexico and Canada

Why it was recalled

Current labeling indicates that cycling improves device longevity in every programming scenario. However, enabling cycling at certain parameter settings may decrease the device battery longevity. With cycling enabled, longevity estimate displayed on the Model 8840Programmer may be inaccurate.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or muscles when connected to an extension and/or lead. The Medtronic InterStim II Neurostimulator, Model 3058, and Medtronic InterStim Neurostimulator, Model 3023, are parts of neurostimulation systems for InterStim Therapy. The neurostimulators are multiprogrammable devices that accommodates a lead through which a stimulation program is delivered. The Medtronic Enterra Neurostimulator, Model 3116, is part of an Enterra Therapy system for gastric electrical stimulation (GES). The neurostimulator is a multiprogrammable device that accommodates a lead through which a stimulation program is delivered.