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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 2

MDR Year MDR Reports MDR Events
2021 5 5
2022 24 24
2023 60 60
2024 93 93
2025 58 58

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 157 157
Material Split, Cut or Torn 11 11
Material Twisted/Bent 11 11
Use of Device Problem 10 10
Unintended Movement 9 9
Device Dislodged or Dislocated 8 8
Expulsion 7 7
Insufficient Information 5 5
Low impedance 5 5
High impedance 4 4
Unintended Electrical Shock 2 2
Material Deformation 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Migration 2 2
Fracture 2 2
Appropriate Term/Code Not Available 2 2
Improper or Incorrect Procedure or Method 2 2
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 23 23
Unspecified Infection 21 21
Low Blood Pressure/ Hypotension 19 19
Implant Pain 19 19
Swelling/ Edema 19 19
Bacterial Infection 18 18
Hematoma 16 16
Post Operative Wound Infection 16 16
Nerve Damage 14 14
Discomfort 9 9
Speech Disorder 9 9
Neck Pain 9 9
Numbness 9 9
Undesired Nerve Stimulation 9 9
Twiddlers Syndrome 8 8
Syncope/Fainting 8 8
Wound Dehiscence 8 8
Pain 8 8
Dyspnea 8 8
Dizziness 7 7
Skin Discoloration 7 7
Heart Failure/Congestive Heart Failure 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Stroke/CVA 6 6
Seroma 6 6
Arrhythmia 5 5
Convulsion/Seizure 5 5
Pulmonary Edema 5 5
Insufficient Information 5 5
Fluid Discharge 5 5
Pocket Erosion 4 4
Dysphagia/ Odynophagia 4 4
Fever 3 3
Paralysis 3 3
Cardiogenic Shock 3 3
Malaise 3 3
Tachycardia 3 3
Myocardial Infarction 3 3
Fatigue 3 3
Headache 3 3
Drug Resistant Bacterial Infection 3 3
High Blood Pressure/ Hypertension 3 3
Dehydration 2 2
Chest Pain 2 2
Pneumonia 2 2
Renal Failure 2 2
Cough 2 2
Hypoxia 2 2
Hemorrhage/Bleeding 2 2
Erythema 2 2

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