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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, carotid sinus nerve
Definition Call for PMAs 12/26/96 (61 FR 50706 (9/27/96))
Product CodeDSR
Regulation Number 870.3850
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
1 0 1 6 3 2

MDR Year MDR Reports MDR Events
2019 1 1
2021 5 5
2022 24 24
2023 60 60
2024 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 68 68
Unintended Movement 7 7
Material Twisted/Bent 7 7
Material Split, Cut or Torn 6 6
Expulsion 5 5
Low impedance 4 4
Fracture 2 2
High impedance 2 2
Material Deformation 2 2
Device Dislodged or Dislocated 2 2
Migration 2 2
Unintended Electrical Shock 1 1
Degraded 1 1
Entrapment of Device 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Unintended System Motion 1 1
Material Separation 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Microbial Contamination of Device 1 1
Component Missing 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 12 12
Post Operative Wound Infection 12 12
Implant Pain 12 12
No Clinical Signs, Symptoms or Conditions 12 12
Hematoma 10 10
Bacterial Infection 10 10
Swelling/ Edema 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Speech Disorder 5 5
Wound Dehiscence 5 5
Low Blood Pressure/ Hypotension 4 4
Nerve Damage 4 4
Syncope/Fainting 4 4
Heart Failure/Congestive Heart Failure 4 4
Twiddlers Syndrome 4 4
Neck Pain 4 4
Dizziness 4 4
Undesired Nerve Stimulation 3 3
Pain 3 3
Seroma 3 3
Skin Discoloration 2 2
Tachycardia 2 2
Pocket Erosion 2 2
Pulmonary Edema 2 2
Myocardial Infarction 2 2
Arrhythmia 2 2
Dysphagia/ Odynophagia 2 2
Dyspnea 2 2
Erythema 2 2
Fatigue 2 2
Fever 2 2
Hiccups 2 2
High Blood Pressure/ Hypertension 2 2
Cellulitis 2 2
Stroke/CVA 2 2
Cardiogenic Shock 2 2
Discomfort 2 2
Numbness 2 2
Fluid Discharge 2 2
Embolism/Embolus 2 2
Thrombocytopenia 1 1
Unspecified Heart Problem 1 1
Hyponatremia 1 1
Muscle/Tendon Damage 1 1
Skin Inflammation/ Irritation 1 1
Drug Resistant Bacterial Infection 1 1
Insufficient Information 1 1
Shock from Patient Lead(s) 1 1
Balance Problems 1 1
Convulsion/Seizure 1 1
Thromboembolism 1 1
Malaise 1 1
Impaired Healing 1 1
Sore Throat 1 1
Therapeutic Response, Decreased 1 1
Electrolyte Imbalance 1 1
Subclinical Infection 1 1
Dehydration 1 1
Inflammation 1 1
Ischemia 1 1
Muscle Weakness 1 1
Headache 1 1
Bradycardia 1 1
Nausea 1 1
Failure of Implant 1 1
Paralysis 1 1
Pneumonia 1 1
Loss of Range of Motion 1 1
Renal Failure 1 1
Transient Ischemic Attack 1 1
Vomiting 1 1

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