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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
High impedance 3 3
Insufficient Information 3 3
Fracture 3 3
Device Dislodged or Dislocated 3 3
Improper or Incorrect Procedure or Method 2 2
Material Deformation 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Migration 2 2
Microbial Contamination of Device 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
Defective Component 1 1
Appropriate Term/Code Not Available 1 1
Unintended System Motion 1 1
Degraded 1 1
Component Missing 1 1
Structural Problem 1 1
Material Separation 1 1
Detachment of Device or Device Component 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
Bacterial Infection 13 13
Implant Pain 13 13
Swelling/ Edema 12 12
Low Blood Pressure/ Hypotension 11 11
Hematoma 11 11
Syncope/Fainting 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Speech Disorder 6 6
Wound Dehiscence 6 6
Neck Pain 6 6
Pulmonary Edema 5 5
Heart Failure/Congestive Heart Failure 5 5
Dyspnea 5 5
Nerve Damage 5 5
Dizziness 5 5
Pocket Erosion 4 4
Undesired Nerve Stimulation 4 4
Pain 4 4
Twiddlers Syndrome 4 4
Seroma 4 4
Skin Discoloration 4 4
Arrhythmia 4 4
Patient Problem/Medical Problem 3 3
High Blood Pressure/ Hypertension 3 3
Fluid Discharge 3 3
Stroke/CVA 3 3
Dysphagia/ Odynophagia 3 3
Malaise 3 3
Numbness 3 3
Cardiogenic Shock 3 3
Myocardial Infarction 3 3
Fever 3 3
Convulsion/Seizure 3 3
Fatigue 3 3
Tachycardia 2 2
Discomfort 2 2
Erythema 2 2
Vomiting 2 2
Cellulitis 2 2
Nausea 2 2
Hiccups 2 2
Headache 2 2
Embolism/Embolus 2 2
Sepsis 2 2
Unspecified Heart Problem 1 1
Hypoxia 1 1
Thrombocytopenia 1 1

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