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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 155 155

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 786 786
Unexpected Therapeutic Results 192 192
Migration 105 105
High impedance 76 76
Charging Problem 47 47
Wireless Communication Problem 35 35
Battery Problem 29 29
Inappropriate/Inadequate Shock/Stimulation 24 24
Inappropriate or Unexpected Reset 21 21
Use of Device Problem 20 20
Premature Discharge of Battery 19 19
Intermittent Energy Output 19 19
Fracture 14 14
Defective Device 12 12
Low impedance 8 8
Delayed Charge Time 7 7
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
Difficult to Remove 3 3
Energy Output Problem 2 2
Difficult to Insert 2 2
Mechanical 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
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 231 231
No Code Available 198 198
Unspecified Infection 153 153
Bacterial Infection 138 138
Swelling/ Edema 83 83
Shaking/Tremors 82 82
Inadequate Pain Relief 69 69
Pain 61 61
Erosion 57 57
Movement Disorder 52 52
Impaired Healing 47 47
Insufficient Information 46 46
Convulsion/Seizure 43 43
Undesired Nerve Stimulation 42 42
Discomfort 38 38
Wound Dehiscence 36 36
Intracranial Hemorrhage 36 36
Hematoma 34 34
Confusion/ Disorientation 34 34
Fluid Discharge 31 31
Cognitive Changes 31 32
Speech Disorder 30 30
Hemorrhage/Bleeding 25 25
Purulent Discharge 23 23
Edema 23 24
Fall 22 22
Paralysis 19 19
Muscle Weakness 19 19
Inflammation 18 18
Dyskinesia 18 18
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
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
Burning Sensation 9 9
Pneumonia 8 8
Swelling 8 8
Hypersensitivity/Allergic reaction 8 8
High Blood Pressure/ Hypertension 7 7
Pocket Erosion 7 7
Cerebrospinal Fluid Leakage 7 7
Chest Pain 7 7
Anxiety 7 8
Weakness 6 7
Depression 6 7
Post Operative Wound Infection 6 6
Unspecified Musculoskeletal problem 6 6
Ischemia Stroke 6 6
Paresthesia 6 6
Fatigue 6 6
Death 5 5
Cardiac Arrest 5 5
Pulmonary Embolism 5 5
Rash 5 5
Scar Tissue 5 5
Electric Shock 5 5
Unspecified Mental, Emotional or Behavioural Problem 5 5
Loss of consciousness 5 5
Numbness 4 4
Vomiting 4 4
Blurred Vision 4 4
Syncope/Fainting 4 4
Patient Problem/Medical Problem 4 4
Balance Problems 4 4
Device Overstimulation of Tissue 4 4
Failure of Implant 4 4
Nausea 4 4
Muscular Rigidity 3 3
Itching Sensation 3 3
Sepsis 3 3
Bruise/Contusion 3 3
Dyspnea 3 3
Cerebral Edema 3 3
Sleep Dysfunction 3 3
Suicidal Ideation 3 3
Visual Disturbances 3 3
Complaint, Ill-Defined 3 3
Urinary Incontinence 3 3
Coma 2 2
Encephalitis 2 2
Tissue Damage 2 2
Urinary Tract Infection 2 2
Brain Injury 2 2
Unspecified Heart Problem 2 2
Unspecified Eye / Vision Problem 2 2
Weight Changes 2 2
Atrial Fibrillation 2 2
Erythema 2 2
Bone Fracture(s) 2 2

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