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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)
2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 1 0 1 6 3 2

MDR Year MDR Reports MDR Events
2016 1 1
2017 3 3
2018 1 1
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 97 97
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
Fracture 3 3
Device Dislodged or Dislocated 3 3
High impedance 3 3
Insufficient Information 2 2
Material Deformation 2 2
Migration 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Improper or Incorrect Procedure or Method 2 2
Unintended Electrical Shock 1 1
Microbial Contamination of Device 1 1
Component Missing 1 1
Appropriate Term/Code Not Available 1 1
Defective Component 1 1
Degraded 1 1
Migration or Expulsion of Device 1 1
Entrapment of Device 1 1
Structural Problem 1 1
Detachment of Device or Device Component 1 1
Material Separation 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 16 16
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
Speech Disorder 6 6
Wound Dehiscence 6 6
Neck Pain 6 6
Pulmonary Edema 5 5
Heart Failure/Congestive Heart Failure 5 5
Dyspnea 5 5
Nerve Damage 5 5
Dizziness 5 5
Pocket Erosion 4 4
Undesired Nerve Stimulation 4 4
Pain 4 4
Twiddlers Syndrome 4 4
Seroma 4 4
Skin Discoloration 4 4
Arrhythmia 4 4
Patient Problem/Medical Problem 3 3
High Blood Pressure/ Hypertension 3 3
Fluid Discharge 3 3
Stroke/CVA 3 3
Dysphagia/ Odynophagia 3 3
Malaise 3 3
Numbness 3 3
Cardiogenic Shock 3 3
Myocardial Infarction 3 3
Fever 3 3
Convulsion/Seizure 3 3
Fatigue 3 3
Tachycardia 2 2
Discomfort 2 2
Erythema 2 2
Vomiting 2 2
Cellulitis 2 2
Nausea 2 2
Hiccups 2 2
Headache 2 2
Embolism/Embolus 2 2
Sepsis 2 2
Unspecified Heart Problem 1 1
Hypoxia 1 1
Thrombocytopenia 1 1

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