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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 2 3 4 2 2 2 7 7 4

MDR Year MDR Reports MDR Events
2017 5 5
2018 2 2
2019 33 33
2020 28 28
2021 35 35
2022 29 29
2023 29 29
2024 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 158 158
Insufficient Information 36 36
No Apparent Adverse Event 3 3
Use of Device Problem 2 2
Patient-Device Incompatibility 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unexpected Therapeutic Results 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Ambulation Difficulties 41 41
Numbness 39 39
Muscle Weakness 38 38
Balance Problems 26 26
No Code Available 18 18
Speech Disorder 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Dysgeusia 8 8
Burn(s) 8 8
Pain 7 7
Dizziness 7 7
Weakness 7 7
Shaking/Tremors 6 6
Paresthesia 6 6
Movement Disorder 6 6
Tingling 4 4
Paresis 4 4
Paralysis 4 4
Dysphasia 3 3
Patient Problem/Medical Problem 3 3
Stroke/CVA 3 3
Ischemia Stroke 2 2
Headache 2 2
Vomiting 2 2
Thrombosis/Thrombus 2 2
Unspecified Nervous System Problem 2 2
Confusion/ Disorientation 2 2
Blister 2 2
Sleep Dysfunction 2 2
Edema 2 2
Taste Disorder 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Nausea 2 2
Lethargy 1 1
High Blood Pressure/ Hypertension 1 1
Excessive Tear Production 1 1
Increased Sensitivity 1 1
Death 1 1
Inadequate Pain Relief 1 1
Hypoesthesia 1 1
Hyponatremia 1 1
Blurred Vision 1 1
Tissue Damage 1 1
Myocardial Infarction 1 1
Tactile Disorders 1 1
Fatigue 1 1
Dysphagia/ Odynophagia 1 1
Calcium Deposits/Calcification 1 1
Fluid Discharge 1 1
Pneumonia 1 1

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