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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)
2020 2021 2022 2023 2024 2025
0 1 0 0 0 0

MDR Year MDR Reports MDR Events
2020 15 15
2021 202 202
2022 294 294
2023 543 543
2024 493 493
2025 64 64

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 359 359
Material Integrity Problem 311 311
Adverse Event Without Identified Device or Use Problem 244 244
Battery Problem 198 198
Charging Problem 188 188
Insufficient Information 170 170
Failure to Deliver Energy 161 161
Inappropriate/Inadequate Shock/Stimulation 153 153
Communication or Transmission Problem 145 145
High impedance 135 135
Failure to Power Up 98 98
Failure to Interrogate 92 92
Energy Output Problem 79 79
Improper or Incorrect Procedure or Method 67 67
Break 56 56
Low impedance 54 54
Impedance Problem 46 46
Electromagnetic Compatibility Problem 45 45
Migration or Expulsion of Device 44 44
Malposition of Device 41 41
Display or Visual Feedback Problem 36 36
Unintended Collision 34 34
Delayed Charge Time 29 29
Premature Discharge of Battery 28 28
Material Frayed 27 27
Intermittent Continuity 25 25
Patient Device Interaction Problem 24 24
No Device Output 22 22
Unstable 21 21
Overheating of Device 19 19
Therapeutic or Diagnostic Output Failure 17 17
Electromagnetic Interference 16 16
Therapy Delivered to Incorrect Body Area 14 14
Loss of Data 10 10
Application Program Problem 9 9
Unexpected Therapeutic Results 7 7
Material Deformation 7 7
Positioning Problem 6 6
Use of Device Problem 6 6
Audible Prompt/Feedback Problem 6 6
Data Problem 6 6
Corroded 5 5
Operating System Becomes Nonfunctional 5 5
Difficult to Open or Close 4 4
Pocket Stimulation 4 4
Noise, Audible 4 4
Difficult to Remove 4 4
Human-Device Interface Problem 3 3
Vibration 3 3
Device Contamination with Chemical or Other Material 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 948 948
Shaking/Tremors 249 249
Insufficient Information 207 207
Electric Shock 153 153
Unspecified Infection 76 76
Ambulation Difficulties 59 59
Dysphasia 54 54
Pain 50 50
Paresthesia 49 49
Discomfort 29 29
Erosion 28 28
Fall 23 23
Convulsion/Seizure 19 19
Stroke/CVA 17 17
Cognitive Changes 17 17
Numbness 16 16
Undesired Nerve Stimulation 15 15
Intracranial Hemorrhage 15 15
Dizziness 15 15
Headache 14 14
Burning Sensation 13 13
Swelling/ Edema 13 13
Device Overstimulation of Tissue 12 12
Bacterial Infection 11 11
Wound Dehiscence 11 11
Muscle Weakness 10 10
Pocket Erosion 10 10
Scar Tissue 8 8
Muscular Rigidity 8 8
Erythema 8 8
Purulent Discharge 8 8
Fluid Discharge 7 7
Skin Erosion 7 7
Confusion/ Disorientation 7 7
Cramp(s) /Muscle Spasm(s) 7 7
Visual Impairment 6 6
Unspecified Tissue Injury 6 6
Memory Loss/Impairment 6 6
Loss of consciousness 6 6
Transient Ischemic Attack 5 5
Fatigue 5 5
Neck Stiffness 5 5
Hemorrhage/Bleeding 5 5
Paresis 5 5
Sleep Dysfunction 5 5
High Blood Pressure/ Hypertension 5 5
Tissue Breakdown 4 4
Bruise/Contusion 4 4
Inflammation 4 4
Hematoma 4 4

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