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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 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 249 249
Use of Device Problem 17 17
Material Split, Cut or Torn 14 14
Material Twisted/Bent 12 12
Unintended Movement 11 11
Device Dislodged or Dislocated 10 10
Expulsion 7 7
Insufficient Information 7 7
Low impedance 6 6
High impedance 4 4
Fracture 3 3
Unintended Electrical Shock 2 2
Material Fragmentation 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
Positioning Problem 1 1
Microbial Contamination of Device 1 1
Degraded 1 1
Impedance Problem 1 1
Component Missing 1 1
Use of Incorrect Control/Treatment Settings 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
Swelling/ Edema 34 34
No Clinical Signs, Symptoms or Conditions 31 31
Unspecified Infection 29 29
Hematoma 29 29
Implant Pain 29 29
Low Blood Pressure/ Hypotension 26 26
Nerve Damage 25 25
Bacterial Infection 19 19
Discomfort 17 17
Post Operative Wound Infection 17 17
Neck Pain 14 14
Numbness 14 14
Twiddlers Syndrome 13 13
Heart Failure/Congestive Heart Failure 13 13
Undesired Nerve Stimulation 12 12
Syncope/Fainting 11 11
Speech Disorder 11 11
Dizziness 11 11
Wound Dehiscence 10 10
Dyspnea 10 10
Stroke/CVA 9 9
Pain 9 9
Insufficient Information 7 7
Skin Discoloration 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Pocket Erosion 6 6
Seroma 6 6
Pulmonary Edema 6 6
Paralysis 5 5
Cardiac Arrest 5 5
Fluid Discharge 5 5
Convulsion/Seizure 5 5
Fatigue 5 5
Drug Resistant Bacterial Infection 5 5
Hemorrhage/Bleeding 5 5
Arrhythmia 5 5
Tachycardia 4 4
Dysphagia/ Odynophagia 4 4
Myocardial Infarction 4 4
Dehydration 4 4
Malaise 3 3
Cough 3 3
Pneumonia 3 3
Peripheral Edema 3 3
Respiratory Arrest 3 3
Sepsis 3 3
Nausea 3 3
Headache 3 3
Fever 3 3
High Blood Pressure/ Hypertension 3 3

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