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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, electrical, implanted, for parkinsonian symptoms
Definition Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinsons disease that are not adequately controlled with medication.
Product CodeNHL
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 1 0 1 6 17 11 8 6 12 5

MDR Year MDR Reports MDR Events
2017 3 3
2018 66 66
2019 74 74
2020 146 146
2021 207 207
2022 214 214
2023 412 412
2024 113 113

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 760 760
Unexpected Therapeutic Results 183 183
Migration 104 104
High impedance 74 74
Charging Problem 46 46
Wireless Communication Problem 34 34
Battery Problem 28 28
Inappropriate/Inadequate Shock/Stimulation 23 23
Inappropriate or Unexpected Reset 20 20
Use of Device Problem 19 19
Premature Discharge of Battery 19 19
Intermittent Energy Output 18 18
Fracture 14 14
Defective Device 11 11
Low impedance 8 8
Device Displays Incorrect Message 7 7
Delayed Charge Time 7 7
Positioning Problem 7 7
Overheating of Device 6 6
Migration or Expulsion of Device 5 5
Failure to Disconnect 5 5
Material Twisted/Bent 5 5
Insufficient Information 4 4
Unintended Movement 4 4
Power Problem 3 3
Difficult to Remove 3 3
Mechanical Problem 2 2
Energy Output Problem 2 2
Break 2 2
Inadequate or Insufficient Training 2 2
Device Issue 2 2
Malposition of Device 2 2
Communication or Transmission Problem 2 2
Device Operates Differently Than Expected 2 2
Device Dislodged or Dislocated 2 2
No Apparent Adverse Event 2 2
Device Contaminated During Manufacture or Shipping 1 1
Appropriate Term/Code Not Available 1 1
Unexpected Shutdown 1 1
Environmental Compatibility Problem 1 1
Human-Device Interface Problem 1 1
Impedance Problem 1 1
Patient-Device Incompatibility 1 1
Application Program Problem 1 1
Structural Problem 1 1
Unstable 1 1
Computer Software Problem 1 1
Failure to Deliver Energy 1 1
Defective Alarm 1 1
Difficult to Insert 1 1
Moisture Damage 1 1
Material Separation 1 1
Defibrillation/Stimulation Problem 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 224 224
No Code Available 198 198
Unspecified Infection 148 148
Bacterial Infection 133 133
Swelling/ Edema 79 79
Shaking/Tremors 75 75
Inadequate Pain Relief 69 69
Pain 59 59
Erosion 56 56
Movement Disorder 47 47
Impaired Healing 47 47
Insufficient Information 45 45
Convulsion/Seizure 42 42
Undesired Nerve Stimulation 38 38
Discomfort 37 37
Intracranial Hemorrhage 36 36
Hematoma 33 33
Wound Dehiscence 33 33
Confusion/ Disorientation 33 33
Fluid Discharge 30 30
Cognitive Changes 29 30
Speech Disorder 28 28
Hemorrhage/Bleeding 25 25
Edema 23 24
Fall 21 21
Purulent Discharge 21 21
Muscle Weakness 19 19
Paralysis 18 18
Dyskinesia 17 17
Inflammation 16 16
Seizures 15 15
Stroke/CVA 15 15
Abscess 14 14
Headache 12 12
Skin Inflammation/ Irritation 12 12
No Known Impact Or Consequence To Patient 12 12
Implant Pain 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Dizziness 10 10
Dysphasia 10 10
Hemorrhage, Cerebral 10 10
Emotional Changes 10 10
Neurological Deficit/Dysfunction 10 10
Staphylococcus Aureus 9 9
Fever 9 9
Pneumonia 8 8
Swelling 8 8
Hypersensitivity/Allergic reaction 8 8
Burning Sensation 8 8
Anxiety 7 8
Cerebrospinal Fluid Leakage 7 7
Chest Pain 7 7
High Blood Pressure/ Hypertension 6 6
Pocket Erosion 6 6
Depression 6 7
Post Operative Wound Infection 6 6
Weakness 6 7
Unspecified Musculoskeletal problem 6 6
Ischemia Stroke 6 6
Paresthesia 5 5
Electric Shock 5 5
Unspecified Mental, Emotional or Behavioural Problem 5 5
Loss of consciousness 5 5
Rash 5 5
Scar Tissue 5 5
Death 5 5
Cardiac Arrest 5 5
Pulmonary Embolism 5 5
Fatigue 5 5
Device Overstimulation of Tissue 4 4
Nausea 4 4
Vomiting 4 4
Blurred Vision 4 4
Syncope/Fainting 4 4
Patient Problem/Medical Problem 4 4
Balance Problems 4 4
Cerebral Edema 3 3
Urinary Incontinence 3 3
Failure of Implant 3 3
Visual Disturbances 3 3
Complaint, Ill-Defined 3 3
Sleep Dysfunction 3 3
Numbness 3 3
Muscular Rigidity 3 3
Itching Sensation 3 3
Sepsis 3 3
Dyspnea 3 3
Bruise/Contusion 3 3
Burn(s) 2 2
Diarrhea 2 2
Arrhythmia 2 2
Atrial Fibrillation 2 2
Head Injury 2 2
Tachycardia 2 2
Shock 2 2
Tissue Damage 2 2
Urinary Tract Infection 2 2
Laceration(s) 2 2
Memory Loss/Impairment 2 2
Low Blood Pressure/ Hypotension 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Neuromodulation Corporation II May-26-2020
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