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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)
2019 2020 2021 2022 2023 2024
0 0 0 1 1 1

MDR Year MDR Reports MDR Events
2019 32 32
2020 18 18
2021 36 36
2022 44 44
2023 64 64
2024 52 52

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 81 81
High impedance 43 43
Insufficient Information 35 35
Break 23 23
Battery Problem 22 22
Failure to Deliver Energy 21 21
Malposition of Device 13 13
Communication or Transmission Problem 13 13
Low impedance 13 13
Charging Problem 11 11
Impedance Problem 10 10
Failure to Power Up 9 9
Migration or Expulsion of Device 9 9
Failure to Interrogate 7 7
Unintended Collision 6 6
Energy Output Problem 6 6
Unstable 6 6
Material Integrity Problem 5 5
Intermittent Continuity 5 5
Premature Discharge of Battery 5 5
Display or Visual Feedback Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Application Program Problem 4 4
Loss of Data 4 4
Delayed Charge Time 4 4
Connection Problem 4 4
Overheating of Device 4 4
Electromagnetic Compatibility Problem 4 4
Patient Device Interaction Problem 4 4
Positioning Problem 3 3
Appropriate Term/Code Not Available 3 3
Difficult to Open or Close 3 3
Material Deformation 3 3
Therapeutic or Diagnostic Output Failure 2 2
Vibration 2 2
Electromagnetic Interference 2 2
Therapy Delivered to Incorrect Body Area 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Data Problem 2 2
Difficult to Remove 2 2
Device Damaged by Another Device 2 2
Signal Artifact/Noise 1 1
Peeled/Delaminated 1 1
Disconnection 1 1
Corroded 1 1
Material Disintegration 1 1
Electro-Static Discharge 1 1
Defective Component 1 1
Pocket Stimulation 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 107 107
Convulsion/Seizure 35 35
Insufficient Information 25 25
Unspecified Infection 22 22
No Known Impact Or Consequence To Patient 17 17
Cognitive Changes 14 14
Pain 13 13
Seizures 11 11
Headache 8 8
Fall 6 6
Memory Loss/Impairment 6 6
Depression 6 6
Shaking/Tremors 6 6
Stroke/CVA 5 5
Suicidal Ideation 5 5
Therapeutic Effects, Unexpected 5 5
Dysphasia 4 4
Complaint, Ill-Defined 4 4
Discomfort 4 4
Emotional Changes 4 4
Hematoma 4 4
Fever 4 4
Burning Sensation 4 4
Sleep Dysfunction 3 3
Paresis 3 3
Hemorrhage/Bleeding 3 3
Muscular Rigidity 3 3
Erosion 3 3
Meningitis 3 3
Dizziness 3 3
Anxiety 3 3
Intracranial Hemorrhage 3 3
Therapeutic Response, Decreased 3 3
Visual Impairment 2 2
Scar Tissue 2 2
Erythema 2 2
Vomiting 2 2
Undesired Nerve Stimulation 2 2
Paralysis 2 2
Swelling/ Edema 2 2
Incontinence 2 2
Paresthesia 2 2
Confusion/ Disorientation 2 2
Neurological Deficit/Dysfunction 2 2
Adhesion(s) 2 2
Nausea 2 2
Bacterial Infection 2 2
Fatigue 2 2
Electric Shock 2 2
Loss of consciousness 2 2

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