Recall Z-0125-2014— Medtronic Neuromodulation
Class II · Terminated
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 Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation. Medtronic Activa RC and Activa PC Deep Brain Stimulators are indicated for Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. Activa PC Deep Brain Stimulator is indicated for Therapy for Dystonia. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Indicated as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for individuals 7 years of age and older. Activa PC Deep Brain Stimulator is indicated for Obsessive-Compulsive Disorder. Bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive-compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs). 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
Product description
Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation. Medtronic Activa RC and Activa PC Deep Brain Stimulators are indicated for Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. Activa PC Deep Brain Stimulator is indicated for Therapy for Dystonia. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Indicated as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for individuals 7 years of age and older. Activa PC Deep Brain Stimulator is indicated for Obsessive-Compulsive Disorder. Bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive-compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs)
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.