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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 17 17
2021 36 36
2022 44 44
2023 64 64
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 71 71
High impedance 34 34
Insufficient Information 29 29
Battery Problem 21 21
Break 19 19
Failure to Deliver Energy 19 19
Low impedance 13 13
Communication or Transmission Problem 11 11
Malposition of Device 10 10
Charging Problem 8 8
Migration or Expulsion of Device 8 8
Impedance Problem 8 8
Failure to Interrogate 7 7
Failure to Power Up 7 7
Unstable 6 6
Unintended Collision 6 6
Energy Output Problem 6 6
Premature Discharge of Battery 5 5
Improper or Incorrect Procedure or Method 5 5
Application Program Problem 4 4
Intermittent Continuity 4 4
Material Integrity Problem 4 4
Loss of Data 4 4
Delayed Charge Time 4 4
Electromagnetic Compatibility Problem 3 3
Appropriate Term/Code Not Available 3 3
Positioning Problem 3 3
Display or Visual Feedback Problem 3 3
Connection Problem 3 3
Vibration 2 2
Difficult to Remove 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Electromagnetic Interference 2 2
Overheating of Device 2 2
Therapeutic or Diagnostic Output Failure 2 2
Data Problem 2 2
Patient Device Interaction Problem 2 2
Device Damaged by Another Device 2 2
Difficult to Open or Close 2 2
Material Deformation 2 2
Material Twisted/Bent 1 1
Peeled/Delaminated 1 1
Pocket Stimulation 1 1
Mechanical Problem 1 1
Difficult to Insert 1 1
Corroded 1 1
Degraded 1 1
Material Disintegration 1 1
Therapy Delivered to Incorrect Body Area 1 1
Electro-Static Discharge 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 90 90
Convulsion/Seizure 29 29
Insufficient Information 20 20
Unspecified Infection 19 19
No Known Impact Or Consequence To Patient 17 17
Cognitive Changes 12 12
Seizures 11 11
Pain 9 9
Shaking/Tremors 6 6
Therapeutic Effects, Unexpected 5 5
Stroke/CVA 5 5
Fall 5 5
Headache 4 4
Depression 4 4
Discomfort 4 4
Complaint, Ill-Defined 4 4
Meningitis 3 3
Dysphasia 3 3
Therapeutic Response, Decreased 3 3
Hematoma 3 3
Hemorrhage/Bleeding 3 3
Intracranial Hemorrhage 3 3
Emotional Changes 3 3
Erosion 3 3
Paresis 3 3
Fever 3 3
Memory Loss/Impairment 3 3
Muscular Rigidity 3 3
Suicidal Ideation 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Paresthesia 2 2
Scar Tissue 2 2
Nausea 2 2
Pocket Erosion 2 2
Paralysis 2 2
Neurological Deficit/Dysfunction 2 2
Adhesion(s) 2 2
Bacterial Infection 2 2
Erythema 2 2
Fatigue 2 2
Burning Sensation 2 2
Tingling 2 2
Visual Impairment 2 2
Vomiting 2 2
Sleep Dysfunction 2 2
Ambulation Difficulties 2 2
Confusion/ Disorientation 2 2
Electric Shock 2 2
Weight Changes 1 1
Foreign Body In Patient 1 1
Impaired Healing 1 1
Numbness 1 1
Loss of consciousness 1 1
Irritability 1 1
Neck Stiffness 1 1
Post Operative Wound Infection 1 1
Hip Fracture 1 1
Fracture, Arm 1 1
Malaise 1 1
Weakness 1 1
Loss of Vision 1 1
Twiddlers Syndrome 1 1
Vertigo 1 1
Sepsis 1 1
Twitching 1 1
Dizziness 1 1
Anxiety 1 1
Brain Injury 1 1
Hemorrhage, Subdural 1 1
Failure of Implant 1 1
Incontinence 1 1
Wound Dehiscence 1 1
Arrhythmia 1 1
Bruise/Contusion 1 1
Infarction, Cerebral 1 1
Chest Pain 1 1
Device Overstimulation of Tissue 1 1
Pulmonary Edema 1 1
Pneumonia 1 1
Undesired Nerve Stimulation 1 1
Muscle Weakness 1 1
Head Injury 1 1
Laceration(s) 1 1
Device Embedded In Tissue or Plaque 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Unspecified Tissue Injury 1 1

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