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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 essential tremor
Definition Deep Brain Stimulation for the treatment of essential tremor
Product CodePJS
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 0 0 0 0 0 0 1 0 0 0

MDR Year MDR Reports MDR Events
2016 1 1
2019 1 1
2020 15 15
2021 202 202
2022 294 294
2023 542 542
2024 209 209

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 317 317
Material Integrity Problem 271 271
Adverse Event Without Identified Device or Use Problem 198 198
Charging Problem 157 157
Battery Problem 149 149
Insufficient Information 133 133
Inappropriate/Inadequate Shock/Stimulation 116 116
Failure to Deliver Energy 112 112
Communication or Transmission Problem 104 104
High impedance 98 98
Failure to Power Up 82 82
Failure to Interrogate 64 64
Energy Output Problem 52 52
Improper or Incorrect Procedure or Method 50 50
Low impedance 42 42
Break 38 38
Migration or Expulsion of Device 36 36
Impedance Problem 32 32
Electromagnetic Compatibility Problem 31 31
Malposition of Device 31 31
Unintended Collision 25 25
Premature Discharge of Battery 25 25
Material Frayed 24 24
Display or Visual Feedback Problem 24 24
Delayed Charge Time 21 21
Intermittent Continuity 18 18
Patient Device Interaction Problem 18 18
Unstable 17 17
No Device Output 16 16
Therapy Delivered to Incorrect Body Area 13 13
Therapeutic or Diagnostic Output Failure 13 13
Overheating of Device 11 11
Electromagnetic Interference 10 10
Application Program Problem 9 9
Loss of Data 7 7
Positioning Problem 6 6
Material Deformation 5 5
Use of Device Problem 5 5
Corroded 4 4
Operating System Becomes Nonfunctional 4 4
Data Problem 4 4
Audible Prompt/Feedback Problem 3 3
Human-Device Interface Problem 3 3
Difficult to Open or Close 3 3
Difficult to Remove 3 3
Pocket Stimulation 3 3
Mechanical Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Noise, Audible 2 2
Power Problem 1 1
Unauthorized Access to Computer System 1 1
Appropriate Term/Code Not Available 1 1
Environmental Compatibility Problem 1 1
Material Twisted/Bent 1 1
Device Markings/Labelling Problem 1 1
Difficult to Insert 1 1
Degraded 1 1
Disconnection 1 1
Circuit Failure 1 1
Premature Elective Replacement Indicator 1 1
Peeled/Delaminated 1 1
Inadequacy of Device Shape and/or Size 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 770 770
Shaking/Tremors 187 187
Insufficient Information 157 157
Electric Shock 117 117
Unspecified Infection 65 65
Ambulation Difficulties 46 46
Paresthesia 44 44
Pain 44 44
Dysphasia 41 41
Erosion 18 18
Discomfort 17 17
Convulsion/Seizure 16 16
Fall 15 15
Cognitive Changes 13 13
Dizziness 12 12
Stroke/CVA 12 12
Undesired Nerve Stimulation 12 12
Numbness 12 12
Pocket Erosion 10 10
Headache 10 10
Wound Dehiscence 10 10
Intracranial Hemorrhage 9 9
Device Overstimulation of Tissue 9 9
Swelling/ Edema 9 9
Bacterial Infection 7 7
Scar Tissue 7 7
Burning Sensation 7 7
Skin Erosion 6 6
Purulent Discharge 6 6
Erythema 6 6
Muscle Weakness 6 6
Cramp(s) /Muscle Spasm(s) 6 6
Fluid Discharge 6 6
Neck Stiffness 5 5
Unspecified Tissue Injury 5 5
Hemorrhage/Bleeding 5 5
Transient Ischemic Attack 5 5
Loss of consciousness 5 5
Muscular Rigidity 4 4
Inflammation 4 4
Memory Loss/Impairment 4 4
Fatigue 4 4
Confusion/ Disorientation 4 4
Sleep Dysfunction 3 3
Post Operative Wound Infection 3 3
Foreign Body In Patient 3 3
Tissue Breakdown 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Bruise/Contusion 3 3
High Blood Pressure/ Hypertension 3 3
Hematoma 3 3
Impaired Healing 3 3
Malaise 3 3
Visual Impairment 3 3
Loss of Vision 3 3
Seroma 3 3
Paresis 2 2
Tinnitus 2 2
Inadequate Pain Relief 2 2
Irritability 2 2
Nausea 2 2
Bone Fracture(s) 2 2
Emotional Changes 2 2
Skin Inflammation/ Irritation 2 2
Suicidal Ideation 2 2
Device Embedded In Tissue or Plaque 2 2
Lethargy 2 2
Weight Changes 2 2
Choking 2 2
Respiratory Failure 2 2
Ptosis 1 1
No Known Impact Or Consequence To Patient 1 1
Shock from Patient Lead(s) 1 1
No Information 1 1
Hydrocephalus 1 1
Balance Problems 1 1
Movement Disorder 1 1
Peripheral Nervous Injury 1 1
Speech Disorder 1 1
Thrombosis/Thrombus 1 1
Unspecified Nervous System Problem 1 1
Hallucination 1 1
Decreased Appetite 1 1
Dysphagia/ Odynophagia 1 1
Dyspnea 1 1
Fever 1 1
Burn(s) 1 1
Cellulitis 1 1
Abscess 1 1
Adhesion(s) 1 1
Chest Pain 1 1
Cyst(s) 1 1
Nerve Damage 1 1
Neuropathy 1 1
Hypersensitivity/Allergic reaction 1 1
Hypoglycemia 1 1
Incontinence 1 1
Depression 1 1
Joint Dislocation 1 1
Twitching 1 1

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