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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)
2019 2020 2021 2022 2023 2024
17 11 8 6 12 5

MDR Year MDR Reports MDR Events
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 707 707
Unexpected Therapeutic Results 182 182
Migration 103 103
High impedance 70 70
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
Intermittent Energy Output 18 18
Use of Device Problem 18 18
Premature Discharge of Battery 18 18
Fracture 14 14
Defective Device 10 10
Low impedance 8 8
Device Displays Incorrect Message 7 7
Delayed Charge Time 7 7
Positioning Problem 7 7
Overheating of Device 6 6
Failure to Disconnect 5 5
Material Twisted/Bent 5 5
Unintended Movement 4 4
Insufficient Information 3 3
Power Problem 3 3
Difficult to Remove 3 3
Inadequate or Insufficient Training 2 2
Mechanical Problem 2 2
Migration or Expulsion of Device 2 2
Energy Output Problem 2 2
Device Dislodged or Dislocated 2 2
Environmental Compatibility Problem 1 1
Human-Device Interface Problem 1 1
Impedance Problem 1 1
Communication or Transmission Problem 1 1
Structural Problem 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Application Program Problem 1 1
Off-Label Use 1 1
Unstable 1 1
Material Separation 1 1
Defibrillation/Stimulation Problem 1 1
Defective Alarm 1 1
Difficult to Insert 1 1
Break 1 1
Computer Software Problem 1 1
Failure to Deliver Energy 1 1
Device Contaminated During Manufacture or Shipping 1 1
Appropriate Term/Code Not Available 1 1
No Apparent Adverse Event 1 1
Unexpected Shutdown 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 224 224
No Code Available 190 190
Unspecified Infection 146 146
Bacterial Infection 123 123
Swelling/ Edema 79 79
Shaking/Tremors 75 75
Inadequate Pain Relief 67 67
Erosion 56 56
Pain 53 53
Movement Disorder 47 47
Impaired Healing 46 46
Insufficient Information 45 45
Convulsion/Seizure 42 42
Undesired Nerve Stimulation 38 38
Intracranial Hemorrhage 34 34
Wound Dehiscence 33 33
Discomfort 32 32
Confusion/ Disorientation 31 31
Fluid Discharge 30 30
Hematoma 30 30
Speech Disorder 28 28
Cognitive Changes 28 28
Hemorrhage/Bleeding 24 24
Purulent Discharge 21 21
Fall 20 20
Muscle Weakness 19 19
Paralysis 17 17
Inflammation 16 16
Dyskinesia 16 16
Edema 15 15
Stroke/CVA 15 15
Abscess 13 13
Seizures 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
Headache 10 10
Fever 9 9
Staphylococcus Aureus 9 9
Hemorrhage, Cerebral 9 9
Hypersensitivity/Allergic reaction 8 8
Burning Sensation 8 8
Emotional Changes 7 7
Swelling 7 7
Pneumonia 6 6
Pocket Erosion 6 6
High Blood Pressure/ Hypertension 6 6
Chest Pain 6 6
Unspecified Musculoskeletal problem 6 6
Ischemia Stroke 6 6
Paresthesia 5 5
Unspecified Mental, Emotional or Behavioural Problem 5 5
Electric Shock 5 5
Loss of consciousness 5 5
Post Operative Wound Infection 5 5
Death 5 5
Cerebrospinal Fluid Leakage 5 5
Cardiac Arrest 5 5
Pulmonary Embolism 5 5
Fatigue 5 5
Scar Tissue 5 5
Blurred Vision 4 4
Vomiting 4 4
Weakness 4 4
Rash 4 4
Neurological Deficit/Dysfunction 4 4
Device Overstimulation of Tissue 4 4
Nausea 4 4
Anxiety 4 4
Depression 4 4
Syncope/Fainting 4 4
No Known Impact Or Consequence To Patient 4 4
Balance Problems 4 4
Cerebral Edema 3 3
Urinary Incontinence 3 3
Complaint, Ill-Defined 3 3
Visual Disturbances 3 3
Sleep Dysfunction 3 3
Failure of Implant 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
Low Blood Pressure/ Hypotension 2 2
Hypoxia 2 2
Tachycardia 2 2
Shock 2 2
Urinary Tract Infection 2 2
Laceration(s) 2 2
Memory Loss/Impairment 2 2
Weight Changes 2 2
Encephalitis 2 2
Numbness 2 2
Coma 2 2
Unspecified Eye / Vision Problem 2 2

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