Recall Z-1147-2015— Medtronic Neuromodulation

Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2015-01-09, terminated 2017-09-28. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..

Recalling firm

Medtronic Neuromodulation

Classification

Class II

Status

Terminated

Initiated

2015-01-09

Terminated

2017-09-28

Firm location

Minneapolis, MN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.