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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 2 2
2020 15 15
2021 202 202
2022 294 294
2023 542 542
2024 386 386

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 337 337
Material Integrity Problem 290 290
Adverse Event Without Identified Device or Use Problem 227 227
Charging Problem 177 177
Battery Problem 173 173
Insufficient Information 154 154
Failure to Deliver Energy 136 136
Communication or Transmission Problem 132 132
Inappropriate/Inadequate Shock/Stimulation 129 129
High impedance 117 117
Failure to Power Up 98 98
Failure to Interrogate 80 80
Energy Output Problem 66 66
Improper or Incorrect Procedure or Method 58 58
Low impedance 49 49
Break 46 46
Migration or Expulsion of Device 39 39
Malposition of Device 38 38
Impedance Problem 38 38
Electromagnetic Compatibility Problem 37 37
Display or Visual Feedback Problem 33 33
Unintended Collision 32 32
Premature Discharge of Battery 28 28
Material Frayed 26 26
Delayed Charge Time 25 25
Patient Device Interaction Problem 23 23
Unstable 20 20
Intermittent Continuity 20 20
No Device Output 18 18
Therapeutic or Diagnostic Output Failure 15 15
Electromagnetic Interference 15 15
Therapy Delivered to Incorrect Body Area 14 14
Overheating of Device 13 13
Loss of Data 9 9
Application Program Problem 9 9
Positioning Problem 6 6
Material Deformation 6 6
Data Problem 6 6
Corroded 5 5
Audible Prompt/Feedback Problem 5 5
Use of Device Problem 5 5
Operating System Becomes Nonfunctional 5 5
Human-Device Interface Problem 3 3
Difficult to Remove 3 3
Pocket Stimulation 3 3
Difficult to Open or Close 3 3
Noise, Audible 3 3
Environmental Compatibility Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Mechanical Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 861 861
Shaking/Tremors 216 216
Insufficient Information 191 191
Electric Shock 130 130
Unspecified Infection 75 75
Ambulation Difficulties 52 52
Dysphasia 51 51
Paresthesia 47 47
Pain 46 46
Erosion 24 24
Discomfort 21 21
Fall 20 20
Convulsion/Seizure 18 18
Cognitive Changes 16 16
Numbness 15 15
Stroke/CVA 14 14
Undesired Nerve Stimulation 13 13
Dizziness 13 13
Wound Dehiscence 12 12
Intracranial Hemorrhage 12 12
Pocket Erosion 10 10
Headache 10 10
Swelling/ Edema 9 9
Burning Sensation 9 9
Device Overstimulation of Tissue 9 9
Bacterial Infection 8 8
Fluid Discharge 8 8
Muscle Weakness 8 8
Scar Tissue 7 7
Erythema 7 7
Skin Erosion 7 7
Purulent Discharge 7 7
Loss of consciousness 6 6
Muscular Rigidity 6 6
Cramp(s) /Muscle Spasm(s) 6 6
Hemorrhage/Bleeding 5 5
Neck Stiffness 5 5
Unspecified Tissue Injury 5 5
Confusion/ Disorientation 5 5
Transient Ischemic Attack 5 5
Fatigue 5 5
Memory Loss/Impairment 5 5
Hematoma 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Bruise/Contusion 4 4
High Blood Pressure/ Hypertension 4 4
Sleep Dysfunction 4 4
Tissue Breakdown 4 4
Inflammation 4 4
Visual Impairment 3 3

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