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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)
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 0 1 0 1 6 3 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 1 1
2017 3 3
2018 1 1
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 69 69
Material Twisted/Bent 7 7
Unintended Movement 7 7
Material Split, Cut or Torn 6 6
Expulsion 5 5
Low impedance 4 4
Fracture 3 3
Migration 2 2
Device Dislodged or Dislocated 2 2
High impedance 2 2
Material Deformation 2 2
Insufficient Information 2 2
Microbial Contamination of Device 1 1
Detachment of Device or Device Component 1 1
Entrapment of Device 1 1
Material Separation 1 1
Unintended System Motion 1 1
Structural Problem 1 1
Use of Device Problem 1 1
Component Missing 1 1
Degraded 1 1
Appropriate Term/Code Not Available 1 1
Defective Component 1 1
Improper or Incorrect Procedure or Method 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Migration or Expulsion of Device 1 1
Unintended Electrical Shock 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 13 13
Post Operative Wound Infection 13 13
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
Patient Problem/Medical Problem 3 3
Undesired Nerve Stimulation 3 3
Pain 3 3
Pocket Erosion 3 3
Seroma 3 3
Skin Discoloration 2 2
Tachycardia 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
Numbness 2 2
Cardiogenic Shock 2 2
Discomfort 2 2
Embolism/Embolus 2 2
Fluid Discharge 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
Injury 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
Thromboembolism 1 1
Tissue Breakdown 1 1
Shock from Patient Lead(s) 1 1
Balance Problems 1 1
Convulsion/Seizure 1 1
Dehydration 1 1
Inflammation 1 1
Ischemia 1 1
Muscle Weakness 1 1
Headache 1 1
Erosion 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
Tissue Damage 1 1
Transient Ischemic Attack 1 1
Twiddlers Syndrome 1 1
Vomiting 1 1

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