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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
Regulation Description Carotid sinus nerve stimulator.
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)
2020 2021 2022 2023 2024 2025
0 1 6 3 2 3

MDR Year MDR Reports MDR Events
2021 5 5
2022 24 24
2023 60 60
2024 93 93
2025 117 117

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 203 203
Use of Device Problem 15 15
Material Split, Cut or Torn 13 13
Unintended Movement 11 11
Material Twisted/Bent 11 11
Device Dislodged or Dislocated 9 9
Expulsion 7 7
Insufficient Information 6 6
Low impedance 6 6
High impedance 4 4
Fracture 3 3
Unintended Electrical Shock 2 2
Material Deformation 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Migration 2 2
Appropriate Term/Code Not Available 2 2
Improper or Incorrect Procedure or Method 2 2
Device-Device Incompatibility 1 1
Break 1 1
Entrapment of Device 1 1
Malposition of Device 1 1
Microbial Contamination of Device 1 1
Degraded 1 1
Material Fragmentation 1 1
Impedance Problem 1 1
Component Missing 1 1
Misconnection 1 1
Material Separation 1 1
Defibrillation/Stimulation Problem 1 1
Detachment of Device or Device Component 1 1
Unintended System Motion 1 1
Electrical /Electronic Property Problem 1 1
Loose or Intermittent Connection 1 1
Intermittent Communication Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 27 27
Swelling/ Edema 26 26
Implant Pain 25 25
Unspecified Infection 24 24
Hematoma 23 23
Nerve Damage 21 21
Low Blood Pressure/ Hypotension 21 21
Bacterial Infection 18 18
Post Operative Wound Infection 16 16
Neck Pain 13 13
Heart Failure/Congestive Heart Failure 13 13
Twiddlers Syndrome 12 12
Numbness 11 11
Syncope/Fainting 10 10
Discomfort 10 10
Dyspnea 10 10
Undesired Nerve Stimulation 10 10
Speech Disorder 9 9
Dizziness 9 9
Wound Dehiscence 8 8
Stroke/CVA 8 8
Pain 8 8
Insufficient Information 7 7
Skin Discoloration 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Seroma 6 6
Fluid Discharge 5 5
Pulmonary Edema 5 5
Convulsion/Seizure 5 5
Drug Resistant Bacterial Infection 5 5
Hemorrhage/Bleeding 5 5
Arrhythmia 5 5
Dysphagia/ Odynophagia 4 4
Fatigue 4 4
Pocket Erosion 4 4
Tachycardia 3 3
Malaise 3 3
Respiratory Arrest 3 3
Pneumonia 3 3
Myocardial Infarction 3 3
Peripheral Edema 3 3
Cardiac Arrest 3 3
Nausea 3 3
Dehydration 3 3
Headache 3 3
Fever 3 3
Paralysis 3 3
Cardiogenic Shock 3 3
High Blood Pressure/ Hypertension 3 3
Chest Pain 3 3

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