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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 6

MDR Year MDR Reports MDR Events
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 733 733
Unexpected Therapeutic Results 191 191
Migration 104 104
High impedance 72 72
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
Intermittent Energy Output 19 19
Use of Device Problem 19 19
Premature Discharge of Battery 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
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
Difficult to Insert 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
Break 1 1
Computer Software Problem 1 1
Failure to Deliver Energy 1 1
Unstable 1 1
Material Separation 1 1
Defibrillation/Stimulation Problem 1 1
Off-Label Use 1 1
Defective Alarm 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 231 231
No Code Available 190 190
Unspecified Infection 151 151
Bacterial Infection 128 128
Swelling/ Edema 83 83
Shaking/Tremors 82 82
Inadequate Pain Relief 67 67
Erosion 57 57
Pain 55 55
Movement Disorder 52 52
Insufficient Information 46 46
Impaired Healing 46 46
Convulsion/Seizure 43 43
Undesired Nerve Stimulation 42 42
Wound Dehiscence 36 36
Intracranial Hemorrhage 34 34
Discomfort 33 33
Confusion/ Disorientation 32 32
Fluid Discharge 31 31
Hematoma 31 31
Speech Disorder 30 30
Cognitive Changes 30 30
Hemorrhage/Bleeding 24 24
Purulent Discharge 23 23
Fall 21 21
Muscle Weakness 19 19
Paralysis 18 18
Inflammation 18 18
Dyskinesia 17 17
Edema 15 15
Stroke/CVA 15 15
Abscess 14 14
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
Fever 10 10
Headache 10 10
Staphylococcus Aureus 9 9
Hemorrhage, Cerebral 9 9
Burning Sensation 9 9
Hypersensitivity/Allergic reaction 8 8
High Blood Pressure/ Hypertension 7 7
Emotional Changes 7 7
Pocket Erosion 7 7
Swelling 7 7
Pneumonia 6 6
Fatigue 6 6
Chest Pain 6 6
Unspecified Musculoskeletal problem 6 6
Ischemia Stroke 6 6
Paresthesia 6 6
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
Scar Tissue 5 5
Blurred Vision 4 4
Nausea 4 4
Rash 4 4
Neurological Deficit/Dysfunction 4 4
Device Overstimulation of Tissue 4 4
Failure of Implant 4 4
Vomiting 4 4
Weakness 4 4
Anxiety 4 4
Depression 4 4
Balance Problems 4 4
No Known Impact Or Consequence To Patient 4 4
Syncope/Fainting 4 4
Cerebral Edema 3 3
Suicidal Ideation 3 3
Urinary Incontinence 3 3
Complaint, Ill-Defined 3 3
Numbness 3 3
Sleep Dysfunction 3 3
Itching Sensation 3 3
Visual Disturbances 3 3
Sepsis 3 3
Bruise/Contusion 3 3
Dyspnea 3 3
Low Blood Pressure/ Hypotension 2 2
Hypoxia 2 2
Erythema 2 2
Bone Fracture(s) 2 2
Burn(s) 2 2
Cellulitis 2 2
Diarrhea 2 2
Arrhythmia 2 2
Tachycardia 2 2
Shock 2 2
Urinary Tract Infection 2 2
Laceration(s) 2 2
Memory Loss/Impairment 2 2

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