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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, thalamic, epilepsy, implanted
Product CodeMBX
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
0 0 1 1 1 0

MDR Year MDR Reports MDR Events
2020 18 18
2021 36 36
2022 44 44
2023 62 62
2024 73 73
2025 69 69

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 85 85
High impedance 64 64
Insufficient Information 40 40
Battery Problem 32 32
Failure to Deliver Energy 28 28
Communication or Transmission Problem 20 20
Break 19 19
Malposition of Device 15 15
Charging Problem 15 15
Low impedance 15 15
Impedance Problem 14 14
Migration or Expulsion of Device 13 13
Failure to Interrogate 11 11
Display or Visual Feedback Problem 11 11
Unintended Collision 10 10
Failure to Power Up 10 10
Inappropriate/Inadequate Shock/Stimulation 9 9
Material Integrity Problem 8 8
Connection Problem 7 7
Electromagnetic Compatibility Problem 7 7
Unstable 6 6
Energy Output Problem 6 6
Premature Discharge of Battery 6 6
Intermittent Continuity 6 6
Application Program Problem 5 5
Loss of Data 4 4
Delayed Charge Time 4 4
Improper or Incorrect Procedure or Method 4 4
Therapeutic or Diagnostic Output Failure 4 4
Patient Device Interaction Problem 4 4
Therapy Delivered to Incorrect Body Area 3 3
Difficult to Open or Close 3 3
Overheating of Device 3 3
Appropriate Term/Code Not Available 3 3
Material Deformation 3 3
Positioning Problem 3 3
Vibration 3 3
Data Problem 2 2
Electromagnetic Interference 2 2
Pocket Stimulation 2 2
Operating System Becomes Nonfunctional 2 2
Ambient Noise Problem 1 1
Audible Prompt/Feedback Problem 1 1
Difficult to Insert 1 1
Defective Component 1 1
Electro-Static Discharge 1 1
Corroded 1 1
Peeled/Delaminated 1 1
Mechanical Problem 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 159 159
Convulsion/Seizure 50 50
Insufficient Information 36 36
Unspecified Infection 27 27
Pain 15 15
Cognitive Changes 11 11
Discomfort 10 10
Headache 10 10
Electric Shock 9 9
No Known Impact Or Consequence To Patient 7 7
Memory Loss/Impairment 6 6
Suicidal Ideation 5 5
Intracranial Hemorrhage 5 5
Shaking/Tremors 5 5
Dysphasia 5 5
Emotional Changes 4 4
Seizures 4 4
Stroke/CVA 4 4
Hemorrhage/Bleeding 4 4
Paresthesia 4 4
Fever 4 4
Depression 4 4
Erosion 3 3
Dizziness 3 3
Meningitis 3 3
Incontinence 3 3
Device Overstimulation of Tissue 3 3
Fall 3 3
Sleep Dysfunction 3 3
Burning Sensation 3 3
Muscular Rigidity 3 3
Bacterial Infection 2 2
Therapeutic Response, Decreased 2 2
Swelling/ Edema 2 2
Unspecified Tissue Injury 2 2
Anxiety 2 2
Undesired Nerve Stimulation 2 2
Scar Tissue 2 2
Loss of consciousness 2 2
Laceration(s) 2 2
Dyspnea 2 2
Irritability 2 2
Pocket Erosion 2 2
Ambulation Difficulties 2 2
Numbness 2 2
Vomiting 2 2
Erythema 2 2
Confusion/ Disorientation 2 2
Malaise 2 2
Hematoma 2 2

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