Medtronic Neuromodulation - Percept PC Implantable Neurostimulator (INS) - Class 2 Recall
Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 17, 2020 Category: Medical Devices Source Type: alerts
Boston Scientific Neuromodulation Corporation - None - Class 2 Recall
Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to advanced levodopa-responsive Parkinson s disease (PD) that are not adequately controlled with medication. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 27, 2020 Category: Medical Devices Source Type: alerts
Medtronic Neuromodulation - RestoreUltra and RestoreSensor - Class 2 Recall
Medtronic, Restore¿ (37711), RestoreADVANCED¿ (37713), RestoreADVANCED¿ SureScan¿ MRI (97713), RestoreSENSOR¿ (37714), RestoreSENSOR¿ SureScan¿ MRI (97714),PrimeAdvanced¿ SureScan MRI, (97702),RestoreULTRA¿ (37712),RestoreULTRA¿ SureScan¿ MRI (97712) Itrel¿4 (37703),Itrel¿4 (37704),RestorePrime¿ (37701),PrimeAdvanced¿ (37702), Spinal cord Stimulation for chronic pain. All Restore, PrimeAdvanced¿ and Itrel 4 devices are used for Spinal Cord Stimulation. All Activa devices are used for Deep Brain Stimulation. Restore¿ (Model 37711),...
Source: Medical Device Recalls - April 30, 2014 Category: Medical Equipment Source Type: alerts
Medtronic Neuromodulation - Activa PC and Activa RC - Class 2 Recall
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 o...
Source: Medical Device Recalls - November 1, 2013 Category: Medical Equipment Source Type: alerts
Medtronic Neuromodulation - Deep Brain Stimulation Lead Kit - Class 1 Recall
Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system delivers electrical stimulation to selected targets in the brain. DBS Leads are indicated for Dystonia, Essential Tremor (ET), Obsessive-Compulsive Disorder (OCD), Parkinson s Disease (PD), and epilepsy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 2, 2013 Category: Medical Equipment Source Type: alerts
Advanced Neuromodulation Systems Inc. - Brio DBS System - Class 2 Recall
The Brio DBS System consists of a rechargeable implantable neurostimulator, also referred to as IPG or R-IPG, which is used with four-electrode leads and extensions of various lengths and is programmed by an external programmer. The IPG can also be controlled by a patient controller and is recharged by a portable charger. This system is designed to deliver electrical stimulation in various combinations of amplitude, pulse width, and frequency to specific targets in the brain. The IPG, leads, and extensions comprise the implantable components of the Brio DBS System. Brio" DBS IPG Model 6788 Implantable Pulse Generator ...
Source: Medical Device Recalls - March 1, 2013 Category: Medical Equipment Source Type: alerts
