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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mr-guided focused ultrasound system
Definition An MR-Guided Focused Ultrasound System is intended to use high intensity focused ultrasound (HiFU) to heat and ablate soft tissue in the brain to treat neurological disorders. MR imaging and thermal mapping are used to plan and monitor the use of the device during the procedure.
Product CodePOH
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
2 2 2 7 7 4

MDR Year MDR Reports MDR Events
2019 33 33
2020 28 28
2021 35 35
2022 29 29
2023 29 29
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 145 145
Insufficient Information 26 26
Therapeutic or Diagnostic Output Failure 1 1
Fluid/Blood Leak 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Ambulation Difficulties 39 39
Numbness 38 38
Muscle Weakness 32 32
Balance Problems 23 23
No Code Available 18 18
Speech Disorder 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Dysgeusia 8 8
Weakness 6 6
Dizziness 5 5
Shaking/Tremors 5 5
Pain 5 5
Movement Disorder 5 5
Paresthesia 5 5
Paralysis 4 4
Tingling 4 4
Burn(s) 4 4
Dysphasia 3 3
Paresis 3 3
Stroke/CVA 3 3
Patient Problem/Medical Problem 3 3
Vomiting 2 2
Ischemia Stroke 2 2
Unspecified Nervous System Problem 2 2
Thrombosis/Thrombus 2 2
Taste Disorder 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Sleep Dysfunction 2 2
Obstruction/Occlusion 1 1
Cognitive Changes 1 1
Confusion/ Disorientation 1 1
Hematuria 1 1
Lethargy 1 1
Bowel Perforation 1 1
Alteration In Body Temperature 1 1
Excessive Tear Production 1 1
Hypoesthesia 1 1
Calcium Deposits/Calcification 1 1
Cardiac Arrest 1 1
Twitching 1 1
Death 1 1
Dysphagia/ Odynophagia 1 1
Fatigue 1 1
Headache 1 1
Intracranial Hemorrhage 1 1
High Blood Pressure/ Hypertension 1 1
Muscle Spasm(s) 1 1
Pneumonia 1 1
Sepsis 1 1
Tissue Damage 1 1
Myocardial Infarction 1 1
Nausea 1 1
Nerve Damage 1 1
Neurological Deficit/Dysfunction 1 1
Hyponatremia 1 1
Unspecified Kidney or Urinary Problem 1 1
Blister 1 1
Urinary Incontinence 1 1
Insufficient Information 1 1
Tactile Disorders 1 1
Hemorrhagic Stroke 1 1

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