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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 0 0 1 0 0 0 1 1 1

MDR Year MDR Reports MDR Events
2018 8 8
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 85 85
High impedance 43 43
Insufficient Information 35 35
Break 24 24
Battery Problem 23 23
Failure to Deliver Energy 21 21
Malposition of Device 14 14
Low impedance 14 14
Communication or Transmission Problem 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
Unstable 6 6
Unintended Collision 6 6
Energy Output Problem 6 6
Premature Discharge of Battery 5 5
Display or Visual Feedback Problem 5 5
Material Integrity Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Intermittent Continuity 5 5
Delayed Charge Time 4 4
Application Program Problem 4 4
Loss of Data 4 4
Electromagnetic Compatibility Problem 4 4
Connection Problem 4 4
Overheating of Device 4 4
Patient Device Interaction Problem 4 4
Positioning Problem 3 3
Material Deformation 3 3
Difficult to Open or Close 3 3
Appropriate Term/Code Not Available 3 3
Therapy Delivered to Incorrect Body Area 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Difficult to Remove 2 2
Device Damaged by Another Device 2 2
Electromagnetic Interference 2 2
Data Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Vibration 2 2
Mechanical Problem 1 1
Pocket Stimulation 1 1
Difficult to Insert 1 1
Degraded 1 1
Material Twisted/Bent 1 1
Defective Component 1 1
Device Contamination with Chemical or Other Material 1 1
Electro-Static Discharge 1 1
Material Disintegration 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 23 23
No Known Impact Or Consequence To Patient 20 20
Cognitive Changes 15 15
Seizures 14 14
Pain 13 13
Headache 8 8
Fall 7 7
Depression 7 7
Shaking/Tremors 6 6
Memory Loss/Impairment 6 6
Complaint, Ill-Defined 6 6
Suicidal Ideation 5 5
Fever 5 5
Therapeutic Effects, Unexpected 5 5
Emotional Changes 5 5
Stroke/CVA 5 5
Dysphasia 4 4
Sleep Dysfunction 4 4
Discomfort 4 4
Burning Sensation 4 4
Anxiety 4 4
Hematoma 4 4
Paresis 3 3
Muscular Rigidity 3 3
Intracranial Hemorrhage 3 3
Irritability 3 3
Therapeutic Response, Decreased 3 3
Loss of consciousness 3 3
Erosion 3 3
Meningitis 3 3
Dizziness 3 3
Hemorrhage/Bleeding 3 3
Bacterial Infection 2 2
Adhesion(s) 2 2
Incontinence 2 2
Neurological Deficit/Dysfunction 2 2
Swelling/ Edema 2 2
Confusion/ Disorientation 2 2
Test Result 2 2
Paresthesia 2 2
Pocket Erosion 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Paralysis 2 2
Tingling 2 2
Undesired Nerve Stimulation 2 2
Erythema 2 2
Vomiting 2 2

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