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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)
2021 2022 2023 2024 2025 2026
1 6 3 2 3 0

MDR Year MDR Reports MDR Events
2021 5 5
2022 24 24
2023 60 60
2024 93 93
2025 137 137
2026 90 90

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 282 282
Use of Device Problem 18 18
Material Twisted/Bent 17 17
Material Split, Cut or Torn 16 16
Unintended Movement 13 13
Device Dislodged or Dislocated 12 12
Expulsion 9 9
Low impedance 6 6
Insufficient Device Problem Information 6 6
High impedance 5 5
Appropriate Device Problem Term/Code Not Available 4 4
Fracture 3 3
Improper or Incorrect Procedure or Method 2 2
Migration 2 2
Detachment of Device or Device Component 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Defibrillation/Stimulation Problem 2 2
Material Deformation 2 2
Unintended Electrical Shock 2 2
Device-Device Incompatibility 2 2
Component Missing 1 1
Impedance Problem 1 1
Lack of Effect 1 1
Use of Incorrect Control/Treatment Settings 1 1
Misconnection 1 1
Unraveled Material 1 1
Material Separation 1 1
Material Fragmentation 1 1
Degraded 1 1
Microbial Contamination of Device 1 1
Material Protrusion/Extrusion 1 1
No Apparent Adverse Event 1 1
Positioning Problem 1 1
Malposition of Device 1 1
Entrapment of Device 1 1
Break 1 1
Unintended System Motion 1 1
Electrical /Electronic Property Problem 1 1
Loose or Intermittent Connection 1 1
Intermittent Communication Failure 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 40 40
Swelling/ Edema 39 39
Implant Pain 34 34
Hematoma 34 34
Nerve Damage 30 30
Unspecified Infection 29 29
Low Blood Pressure/ Hypotension 28 28
Discomfort 24 24
Bacterial Infection 23 23
Post Operative Wound Infection 22 22
Twiddlers Syndrome 18 18
Undesired Nerve Stimulation 18 18
Numbness 17 17
Wound Dehiscence 15 15
Neck Pain 14 14
Heart Failure/Congestive Heart Failure 13 13
Dizziness 12 12
Facial Paralysis 11 11
Syncope/Fainting 11 11
Speech Disorder 11 11
Dyspnea 11 11
Stroke/CVA 10 10
Pain 10 10
Insufficient Information 8 8
Voice alteration 8 8
Hemorrhage/Blood Loss/Bleeding 7 7
Skin Discoloration 7 7
Medical device site infection 7 7
Pocket Erosion 7 7
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 7 7
Pulmonary Edema 6 6
Cardiac Arrest 6 6
Fatigue 6 6
Paralysis 6 6
Seroma 6 6
Tachycardia 5 5
Convulsion/Seizure 5 5
Fluid Discharge 5 5
Drug Resistant Bacterial Infection 5 5
Arrhythmia 5 5
Dysphagia/ Odynophagia 4 4
Myocardial Infarction 4 4
Cellulitis 4 4
Headache 4 4
Dehydration 4 4
High Blood Pressure/ Hypertension 4 4
Cough 3 3
Malaise 3 3
Pneumonia 3 3
Peripheral Edema 3 3

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