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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 10

MDR Year MDR Reports MDR Events
2019 74 74
2020 146 146
2021 207 207
2022 214 214
2023 412 412
2024 312 312

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 812 812
Unexpected Therapeutic Results 232 232
Migration 121 121
High impedance 84 84
Charging Problem 56 56
Wireless Communication Problem 40 40
Battery Problem 31 31
Inappropriate/Inadequate Shock/Stimulation 29 29
Intermittent Energy Output 24 24
Inappropriate or Unexpected Reset 21 21
Premature Discharge of Battery 21 21
Use of Device Problem 20 20
Fracture 17 17
Defective Device 14 14
Low impedance 10 10
Positioning Problem 9 9
Overheating of Device 8 8
Delayed Charge Time 8 8
Device Displays Incorrect Message 7 7
Off-Label Use 5 5
Material Twisted/Bent 5 5
Failure to Disconnect 5 5
Unintended Movement 4 4
Difficult to Remove 4 4
Power Problem 4 4
Insufficient Information 3 3
Mechanical Problem 2 2
Migration or Expulsion of Device 2 2
Communication or Transmission Problem 2 2
Energy Output Problem 2 2
Difficult to Insert 2 2
Device Dislodged or Dislocated 2 2
Inadequate or Insufficient Training 2 2
Environmental Compatibility Problem 1 1
Structural Problem 1 1
Impedance Problem 1 1
Application Program Problem 1 1
Difficult to Open or Close 1 1
Human-Device Interface Problem 1 1
Computer Software Problem 1 1
Appropriate Term/Code Not Available 1 1
Defective Alarm 1 1
Defibrillation/Stimulation Problem 1 1
No Apparent Adverse Event 1 1
Material Separation 1 1
Patient-Device Incompatibility 1 1
Break 1 1
Malposition of Device 1 1
Unexpected Shutdown 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 262 262
No Code Available 190 190
Unspecified Infection 159 159
Bacterial Infection 148 148
Shaking/Tremors 107 107
Swelling/ Edema 98 98
Movement Disorder 69 69
Inadequate Pain Relief 68 68
Erosion 67 67
Insufficient Information 59 59
Pain 57 57
Impaired Healing 50 50
Undesired Nerve Stimulation 49 49
Wound Dehiscence 44 44
Convulsion/Seizure 44 44
Discomfort 43 43
Intracranial Hemorrhage 40 40
Confusion/ Disorientation 36 36
Hematoma 36 36
Speech Disorder 34 34
Cognitive Changes 31 31
Fluid Discharge 31 31
Hemorrhage/Bleeding 29 29
Purulent Discharge 28 28
Fall 25 25
Muscle Weakness 22 22
Inflammation 21 21
Paralysis 20 20
Dyskinesia 18 18
Edema 15 15
Headache 15 15
Stroke/CVA 15 15
Abscess 14 14
Skin Inflammation/ Irritation 12 12
Seizures 12 12
Implant Pain 12 12
Erythema 12 12
Burning Sensation 12 12
Fever 12 12
Unspecified Musculoskeletal problem 11 11
Dysphasia 11 11
Dizziness 10 10
Pocket Erosion 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Paresthesia 10 10
Hemorrhage, Cerebral 9 9
Hypersensitivity/Allergic reaction 9 9
Staphylococcus Aureus 9 9
Emotional Changes 7 7
Swelling 7 7

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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