Recall Z-0124-2014— Medtronic Neuromodulation

Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2013-09-30, terminated 2015-11-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: - Failed Back Syndrome (FBS) or low back syndrome or failed back - Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk - Postlaminectomy pain - Multiple back operations - Unsuccessful disk surgery - Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions - Peripheral causalgia - Epidural fibrosis - Arachnoiditis or lumbar adhesive arachnoiditis - Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia. Reason: Medtronic notified customers regarding over stimulation or stimulation in the wrong area related to select Medtronic neurostimulators. Upon a specific set of conditions, typically related to device recovery from an over discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended..

Recalling firm

Medtronic Neuromodulation

Classification

Class II

Status

Terminated

Initiated

2013-09-30

Terminated

2015-11-20

Firm location

Minneapolis, MN, United States

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