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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 2

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 59 59

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 97 97
Unintended Movement 8 8
Material Split, Cut or Torn 7 7
Material Twisted/Bent 7 7
Expulsion 5 5
Low impedance 4 4
Use of Device Problem 4 4
Device Dislodged or Dislocated 3 3
Fracture 3 3
High impedance 3 3
Insufficient Information 3 3
Migration 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Improper or Incorrect Procedure or Method 2 2
Material Deformation 2 2
Defective Component 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Appropriate Term/Code Not Available 1 1
Unintended System Motion 1 1
Intermittent Communication Failure 1 1
Loose or Intermittent Connection 1 1
Migration or Expulsion of Device 1 1
Entrapment of Device 1 1
Unintended Electrical Shock 1 1
Microbial Contamination of Device 1 1
Degraded 1 1
Component Missing 1 1
Structural Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 16 16
Post Operative Wound Infection 15 15
No Clinical Signs, Symptoms or Conditions 14 14
Implant Pain 13 13
Bacterial Infection 13 13
Swelling/ Edema 12 12
Low Blood Pressure/ Hypotension 11 11
Hematoma 11 11
Neck Pain 6 6
Syncope/Fainting 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Wound Dehiscence 6 6
Speech Disorder 6 6
Nerve Damage 5 5
Dyspnea 5 5
Pulmonary Edema 5 5
Dizziness 5 5
Heart Failure/Congestive Heart Failure 5 5
Seroma 4 4
Skin Discoloration 4 4
Twiddlers Syndrome 4 4
Pain 4 4
Undesired Nerve Stimulation 4 4
Arrhythmia 4 4
Pocket Erosion 4 4
Dysphagia/ Odynophagia 3 3
Fluid Discharge 3 3
Fatigue 3 3
Myocardial Infarction 3 3
Convulsion/Seizure 3 3
Malaise 3 3
Numbness 3 3
Cardiogenic Shock 3 3
Stroke/CVA 3 3
Patient Problem/Medical Problem 3 3
Fever 3 3
High Blood Pressure/ Hypertension 3 3
Tachycardia 2 2
Discomfort 2 2
Headache 2 2
Vomiting 2 2
Erythema 2 2
Hiccups 2 2
Cellulitis 2 2
Embolism/Embolus 2 2
Nausea 2 2
Sepsis 2 2
Tissue Breakdown 1 1
Impaired Healing 1 1
Thromboembolism 1 1

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