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TPLC
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show TPLC since
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Device
stimulator, carotid sinus nerve
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)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
0
0
0
0
0
0
0
0
0
0
1
0
1
6
3
1
MDR Year
MDR Reports
MDR Events
2015
1
1
2016
1
1
2017
3
3
2018
1
1
2019
1
1
2021
5
5
2022
24
24
2023
60
60
2024
19
19
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
69
69
Material Twisted/Bent
7
7
Unintended Movement
7
7
Material Split, Cut or Torn
6
6
Expulsion
5
5
Low impedance
4
4
Fracture
3
3
Migration
2
2
Device Dislodged or Dislocated
2
2
High impedance
2
2
Material Deformation
2
2
Insufficient Information
2
2
Microbial Contamination of Device
1
1
Detachment of Device or Device Component
1
1
Entrapment of Device
1
1
Material Separation
1
1
Unintended System Motion
1
1
Structural Problem
1
1
Use of Device Problem
1
1
Component Missing
1
1
Degraded
1
1
Appropriate Term/Code Not Available
1
1
Defective Component
1
1
Improper or Incorrect Procedure or Method
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Migration or Expulsion of Device
1
1
Unintended Electrical Shock
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
13
13
Post Operative Wound Infection
13
13
Implant Pain
12
12
No Clinical Signs, Symptoms or Conditions
12
12
Hematoma
10
10
Bacterial Infection
10
10
Swelling/ Edema
9
9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Speech Disorder
5
5
Wound Dehiscence
5
5
Low Blood Pressure/ Hypotension
4
4
Nerve Damage
4
4
Syncope/Fainting
4
4
Heart Failure/Congestive Heart Failure
4
4
Twiddlers Syndrome
4
4
Neck Pain
4
4
Dizziness
4
4
Patient Problem/Medical Problem
3
3
Undesired Nerve Stimulation
3
3
Pain
3
3
Pocket Erosion
3
3
Seroma
3
3
Skin Discoloration
2
2
Tachycardia
2
2
Pulmonary Edema
2
2
Myocardial Infarction
2
2
Arrhythmia
2
2
Dysphagia/ Odynophagia
2
2
Dyspnea
2
2
Erythema
2
2
Fatigue
2
2
Fever
2
2
Hiccups
2
2
High Blood Pressure/ Hypertension
2
2
Cellulitis
2
2
Stroke/CVA
2
2
Numbness
2
2
Cardiogenic Shock
2
2
Discomfort
2
2
Embolism/Embolus
2
2
Fluid Discharge
2
2
Thrombocytopenia
1
1
Unspecified Heart Problem
1
1
Hyponatremia
1
1
Muscle/Tendon Damage
1
1
Skin Inflammation/ Irritation
1
1
Drug Resistant Bacterial Infection
1
1
Insufficient Information
1
1
Injury
1
1
Malaise
1
1
Impaired Healing
1
1
Sore Throat
1
1
Therapeutic Response, Decreased
1
1
Electrolyte Imbalance
1
1
Subclinical Infection
1
1
Thromboembolism
1
1
Tissue Breakdown
1
1
Shock from Patient Lead(s)
1
1
Balance Problems
1
1
Convulsion/Seizure
1
1
Dehydration
1
1
Inflammation
1
1
Ischemia
1
1
Muscle Weakness
1
1
Headache
1
1
Erosion
1
1
Bradycardia
1
1
Nausea
1
1
Failure of Implant
1
1
Paralysis
1
1
Pneumonia
1
1
Loss of Range of Motion
1
1
Renal Failure
1
1
Tissue Damage
1
1
Transient Ischemic Attack
1
1
Twiddlers Syndrome
1
1
Vomiting
1
1
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