7 results
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41ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto Rico. Medtronic¿ DBSTM Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Parkinson's Disease is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. STN/GPi target system components: ¿ Kinetra¿ Model 7428 or Soletra¿ Model 7426 Neurostimulator ¿ Activa¿ PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator ¿ Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension ¿ Model 3387 or Model 3389 Lead Medtronic DBS Therapy for Tremor - Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) using Medtronic DBS Therapy for Tremor is indicated for the suppression of tremor in the upper extremity. The system is intended for patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. VIM target system components: ¿ Soletra Model 7426 Neurostimulator ¿ Activa PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator ¿ Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension ¿ Model 3387 or Model 3389 Lead.
FDA Enforcement
Class II
·Terminated·Medtronic Neuromodulation·December 26, 2012
Model 8731SC Intrathecal Catheter Medtronic Inc., Minneapolis, MN 55432 A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy.
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code LKK·April 14, 2008
Medtronic 8578 Sutureless Pump Connector Revision Kit Medtronic Inc., Minneapolis, MN 55432 A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy.
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code LKK·April 14, 2008
Model 8596SC Intrathecal Catheter Pump Segment Revision Kit Medtronic Inc., Minneapolis, MN 55432 A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy.
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code LKK·April 14, 2008
Model 8709SC Indura 1P One-Piece Intrathecal Catheter Medtronic Inc., Minneapolis, MN 55432 A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy.
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code LKK·April 14, 2008
AMS Acticon Neosphincter Pump, Product Number 72402287, Sterilization Method Steam, American Medical systems Inc., 10700 Bren Road West, Minnetonka, MN 55343. The Acticon Neosphincter is an implantable device used to treat severe fecal incontinence in males and females eighteen years and older who have failed, or are not candidates for less invasive forms of restorative therapy.
FDA Recall
Terminated
·American Medical Systems, Inc.·Product code MIP·May 9, 2011
Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto Rico. Medtronic DBSTM Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Parkinson's Disease is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. STN/GPi target system components: Kinetra Model 7428 or Soletra Model 7426 Neurostimulator Activa PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension Model 3387 or Model 3389 Lead Medtronic DBS Therapy for Tremor - Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) using Medtronic DBS Therapy for Tremor is indicated for the suppression of tremor in the upper extremity. The system is intended for patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. VIM target system components: Soletra Model 7426 Neurostimulator Activa PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension Model 3387 or Model 3389 Lead.
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code MHY·December 3, 2012