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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)
2019 2020 2021 2022 2023 2024
1 0 1 6 3 2

MDR Year MDR Reports MDR Events
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 96 96
Unintended Movement 8 8
Material Split, Cut or Torn 7 7
Material Twisted/Bent 7 7
Expulsion 5 5
Use of Device Problem 4 4
Low impedance 4 4
High impedance 3 3
Device Dislodged or Dislocated 3 3
Insufficient Information 2 2
Material Deformation 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Migration 2 2
Fracture 2 2
Improper or Incorrect Procedure or Method 2 2
Entrapment of Device 1 1
Unintended Electrical Shock 1 1
Microbial Contamination of Device 1 1
Degraded 1 1
Component Missing 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Appropriate Term/Code Not Available 1 1
Unintended System Motion 1 1
Loose or Intermittent Connection 1 1
Intermittent Communication Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 15 15
No Clinical Signs, Symptoms or Conditions 14 14
Post Operative Wound Infection 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
Wound Dehiscence 6 6
Speech Disorder 6 6
Neck Pain 6 6
Dyspnea 5 5
Heart Failure/Congestive Heart Failure 5 5
Dizziness 5 5
Nerve Damage 5 5
Pulmonary Edema 5 5
Pain 4 4
Arrhythmia 4 4
Twiddlers Syndrome 4 4
Undesired Nerve Stimulation 4 4
Skin Discoloration 4 4
Seroma 4 4
High Blood Pressure/ Hypertension 3 3
Pocket Erosion 3 3
Stroke/CVA 3 3
Fluid Discharge 3 3
Numbness 3 3
Fatigue 3 3
Cardiogenic Shock 3 3
Convulsion/Seizure 3 3
Myocardial Infarction 3 3
Malaise 3 3
Dysphagia/ Odynophagia 3 3
Fever 3 3
Discomfort 2 2
Vomiting 2 2
Erythema 2 2
Tachycardia 2 2
Cellulitis 2 2
Embolism/Embolus 2 2
Sepsis 2 2
Nausea 2 2
Headache 2 2
Hiccups 2 2
Renal Failure 1 1
Anxiety 1 1
Hypoxia 1 1
Therapeutic Response, Decreased 1 1

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