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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)
2021 2022 2023 2024 2025 2026
0 1 1 1 0 0

MDR Year MDR Reports MDR Events
2021 36 36
2022 44 44
2023 62 63
2024 73 73
2025 83 83
2026 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 87 87
High impedance 67 68
Insufficient Information 42 42
Battery Problem 32 32
Failure to Deliver Energy 31 32
Break 18 18
Communication or Transmission Problem 18 18
Impedance Problem 15 15
Low impedance 14 14
Malposition of Device 14 14
Charging Problem 14 14
Migration or Expulsion of Device 13 13
Display or Visual Feedback Problem 13 13
Failure to Power Up 11 11
Inappropriate/Inadequate Shock/Stimulation 10 10
Unintended Collision 10 10
Failure to Interrogate 10 10
Connection Problem 8 8
Material Integrity Problem 8 8
Electromagnetic Compatibility Problem 7 7
Energy Output Problem 7 7
Premature Discharge of Battery 6 6
Intermittent Continuity 6 6
Therapeutic or Diagnostic Output Failure 5 5
Patient Device Interaction Problem 5 5
Application Program Problem 5 5
Unstable 5 5
Improper or Incorrect Procedure or Method 4 4
Loss of Data 4 4
Vibration 3 3
Delayed Charge Time 3 3
Operating System Becomes Nonfunctional 3 3
Difficult to Open or Close 3 3
Therapy Delivered to Incorrect Body Area 3 3
Overheating of Device 3 3
Positioning Problem 2 2
Data Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Electromagnetic Interference 2 2
Corroded 1 1
Noise, Audible 1 1
Pocket Stimulation 1 1
Appropriate Term/Code Not Available 1 1
Ambient Noise Problem 1 1
Material Deformation 1 1
Audible Prompt/Feedback Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Defective Component 1 1
Peeled/Delaminated 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 170 171
Convulsion/Seizure 58 58
Insufficient Information 36 36
Unspecified Infection 32 32
Pain 16 16
Discomfort 11 11
Cognitive Changes 11 11
Electric Shock 10 10
Headache 9 9
Intracranial Hemorrhage 7 7
Dysphasia 6 6
Shaking/Tremors 5 5
Stroke/CVA 5 5
Fall 5 5
Memory Loss/Impairment 5 5
Suicidal Ideation 5 5
Hemorrhage/Bleeding 5 5
Paresthesia 5 5
Depression 4 4
Burning Sensation 4 4
Swelling/ Edema 3 3
Wound Dehiscence 3 3
Dyspnea 3 3
Emotional Changes 3 3
Dizziness 3 3
Meningitis 3 3
Incontinence 3 3
Device Overstimulation of Tissue 3 3
Erosion 3 3
Muscular Rigidity 3 3
Unspecified Tissue Injury 2 2
Anxiety 2 2
Undesired Nerve Stimulation 2 2
Scar Tissue 2 2
Laceration(s) 2 2
Erythema 2 2
Vomiting 2 2
Numbness 2 2
Fever 2 2
Bacterial Infection 2 2
Confusion/ Disorientation 2 2
Post Operative Wound Infection 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Head Injury 2 2
Malaise 2 2
Hematoma 2 2
Adhesion(s) 2 2
Loss of consciousness 2 2
Nausea 2 2
Pocket Erosion 2 2

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