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TPLC
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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 Code
DSR
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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