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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 6

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 192 192

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 806 806
Unexpected Therapeutic Results 204 204
Migration 109 109
High impedance 77 77
Charging Problem 51 51
Wireless Communication Problem 37 37
Battery Problem 29 29
Inappropriate/Inadequate Shock/Stimulation 25 25
Inappropriate or Unexpected Reset 21 21
Intermittent Energy Output 21 21
Premature Discharge of Battery 20 20
Use of Device Problem 20 20
Fracture 14 14
Defective Device 12 12
Low impedance 8 8
Delayed Charge Time 8 8
Device Displays Incorrect Message 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
Unintended Movement 4 4
Insufficient Information 4 4
Power Problem 3 3
Communication or Transmission Problem 3 3
Difficult to Remove 3 3
Energy Output Problem 2 2
Difficult to Insert 2 2
Mechanical Problem 2 2
Break 2 2
Device Operates Differently Than Expected 2 2
Malposition of Device 2 2
Inadequate or Insufficient Training 2 2
Device Issue 2 2
No Apparent Adverse Event 2 2
Device Dislodged or Dislocated 2 2
Environmental Compatibility Problem 1 1
Human-Device Interface Problem 1 1
Impedance Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Appropriate Term/Code Not Available 1 1
Unexpected Shutdown 1 1
Structural Problem 1 1
Unstable 1 1
Patient-Device Incompatibility 1 1
Application Program Problem 1 1
Difficult to Open or Close 1 1
Computer Software Problem 1 1
Failure to Deliver Energy 1 1
Defective Alarm 1 1
Material Separation 1 1
Defibrillation/Stimulation Problem 1 1
Moisture Damage 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 238 238
No Code Available 198 198
Unspecified Infection 155 155
Bacterial Infection 142 142
Shaking/Tremors 87 87
Swelling/ Edema 84 84
Inadequate Pain Relief 70 70
Pain 62 62
Erosion 60 60
Movement Disorder 57 57
Insufficient Information 48 48
Impaired Healing 48 48
Convulsion/Seizure 43 43
Undesired Nerve Stimulation 43 43
Discomfort 42 42
Wound Dehiscence 37 37
Intracranial Hemorrhage 37 37
Hematoma 35 35
Confusion/ Disorientation 34 34
Speech Disorder 32 32
Cognitive Changes 31 32
Fluid Discharge 31 31
Hemorrhage/Bleeding 26 26
Purulent Discharge 24 24
Edema 23 24
Fall 22 22
Paralysis 20 20
Inflammation 19 19
Muscle Weakness 19 19
Dyskinesia 19 19
Seizures 15 15
Abscess 15 15
Stroke/CVA 15 15
Headache 12 12
No Known Impact Or Consequence To Patient 12 12
Skin Inflammation/ Irritation 12 12
Implant Pain 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Burning Sensation 10 10
Dizziness 10 10
Dysphasia 10 10
Fever 10 10
Hemorrhage, Cerebral 10 10
Emotional Changes 10 10
Neurological Deficit/Dysfunction 10 10
Staphylococcus Aureus 9 9
Pneumonia 8 8
Swelling 8 8
Hypersensitivity/Allergic reaction 8 8
Unspecified Musculoskeletal problem 8 8
Paresthesia 7 7
Anxiety 7 8
High Blood Pressure/ Hypertension 7 7
Pocket Erosion 7 7
Cerebrospinal Fluid Leakage 7 7
Chest Pain 7 7
Fatigue 6 6
Weakness 6 7
Depression 6 7
Post Operative Wound Infection 6 6
Ischemia Stroke 6 6
Electric Shock 5 5
Unspecified Mental, Emotional or Behavioural Problem 5 5
Loss of consciousness 5 5
Death 5 5
Cardiac Arrest 5 5
Pulmonary Embolism 5 5
Rash 5 5
Scar Tissue 5 5
Device Overstimulation of Tissue 4 4
Failure of Implant 4 4
Nausea 4 4
Numbness 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 4 4
Sleep Dysfunction 3 3
Suicidal Ideation 3 3
Visual Disturbances 3 3
Complaint, Ill-Defined 3 3
Muscular Rigidity 3 3
Itching Sensation 3 3
Sepsis 3 3
Arrhythmia 3 3
Bruise/Contusion 3 3
Erythema 3 3
Atrial Fibrillation 3 3
Dyspnea 3 3
Urinary Incontinence 3 3
Bone Fracture(s) 2 2
Head Injury 2 2
Burn(s) 2 2
Cellulitis 2 2
Diarrhea 2 2
Shock 2 2
Tachycardia 2 2
Laceration(s) 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Neuromodulation Corporation II May-24-2024
2 Boston Scientific Neuromodulation Corporation II May-26-2020
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