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TPLC
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Device
drug eluting permanent left ventricular (lv) pacemaker electrode
Definition
Drug eluting permanent lv pacemaker electrodes are used with compatible cardiac rhythm therapy (crt) devices to deliver pacing pulses to the heart.
Product Code
OJX
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
9
41
63
47
41
16
11
27
19
24
21
19
19
9
11
0
MDR Year
MDR Reports
MDR Events
2014
3004
3004
2015
3724
3724
2016
3030
3030
2017
3294
3294
2018
3979
3979
2019
3926
3926
2020
2776
2776
2021
2869
2869
2022
2947
2947
2023
4469
4469
2024
929
929
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
8777
8777
Device Dislodged or Dislocated
8442
8442
High Capture Threshold
6203
6203
Failure to Capture
5079
5079
High impedance
2556
2556
Capturing Problem
1821
1821
Appropriate Term/Code Not Available
1449
1449
Activation, Positioning or Separation Problem
1407
1407
Positioning Problem
1174
1174
Break
884
884
Low impedance
827
827
Impedance Problem
809
809
Fracture
735
735
Difficult to Insert
468
468
Unstable Capture Threshold
440
440
Difficult to Remove
417
417
Intermittent Capture
402
402
Over-Sensing
339
339
Insufficient Information
323
323
Pacing Problem
300
300
Material Integrity Problem
264
264
Device Operates Differently Than Expected
180
180
Ambient Noise Problem
171
171
Signal Artifact/Noise
168
168
Device Sensing Problem
139
139
Therapy Delivered to Incorrect Body Area
124
124
Pocket Stimulation
116
116
Failure to Sense
106
106
Failure to Advance
105
105
Separation Failure
102
102
Difficult To Position
92
92
Connection Problem
88
88
Mechanical Problem
86
86
Therapeutic or Diagnostic Output Failure
77
77
Device Contamination with Body Fluid
75
75
Inappropriate/Inadequate Shock/Stimulation
75
75
Use of Device Problem
71
71
Electrical /Electronic Property Problem
65
65
High Sensing Threshold
62
62
No Pacing
60
60
Accessory Incompatible
59
59
Device Handling Problem
56
56
Under-Sensing
55
55
Defective Device
54
54
Stretched
49
49
Improper or Incorrect Procedure or Method
48
48
Difficult to Advance
43
43
Difficult or Delayed Positioning
35
35
Positioning Failure
35
35
Pacing Inadequately
30
30
Detachment of Device or Device Component
29
29
Material Twisted/Bent
29
29
Output Problem
25
25
Malposition of Device
25
25
Retraction Problem
25
25
Cut In Material
24
24
Material Separation
21
21
Material Deformation
21
21
Failure to Disconnect
20
20
Kinked
19
19
Loose or Intermittent Connection
18
18
Migration or Expulsion of Device
18
18
Nonstandard Device
18
18
Patient-Device Incompatibility
18
18
Product Quality Problem
18
18
Device Contamination with Chemical or Other Material
17
17
Device Damaged by Another Device
16
16
Detachment Of Device Component
15
15
Bent
14
14
Defective Component
14
14
Migration
14
14
Material Split, Cut or Torn
14
14
Structural Problem
13
13
Deformation Due to Compressive Stress
12
12
Naturally Worn
12
12
Human-Device Interface Problem
11
11
Device-Device Incompatibility
11
11
Shelf Life Exceeded
10
10
Defibrillation/Stimulation Problem
9
9
Component Missing
9
9
Collapse
9
9
Physical Resistance/Sticking
9
9
Patient Device Interaction Problem
8
8
Partial Blockage
8
8
Material Erosion
8
8
Misconnection
8
8
Material Puncture/Hole
8
8
Low Sensing Threshold
8
8
Inadequacy of Device Shape and/or Size
7
7
Loss of Threshold
7
7
Electromagnetic Interference
7
7
Premature Discharge of Battery
7
7
Complete Blockage
7
7
No Apparent Adverse Event
7
7
Programming Issue
6
6
Contamination
6
6
Entrapment of Device
6
6
Device Expiration Issue
6
6
Difficult to Flush
6
6
Degraded
6
6
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
13673
13673
No Clinical Signs, Symptoms or Conditions
6672
6672
Unspecified Infection
4267
4267
Muscle Stimulation
2100
2100
Undesired Nerve Stimulation
1969
1969
Death
1284
1284
No Consequences Or Impact To Patient
957
957
Device Overstimulation of Tissue
728
728
Insufficient Information
726
726
Dyspnea
448
448
No Code Available
302
302
Sepsis
298
298
Discomfort
272
272
Twiddlers Syndrome
269
269
Endocarditis
248
248
Pericardial Effusion
224
224
Pocket Erosion
219
219
Vascular Dissection
209
209
Erosion
197
197
Chest Pain
196
196
Fatigue
162
162
Pain
152
152
Dizziness
148
148
Bacterial Infection
147
147
Hematoma
138
138
Erythema
126
126
Heart Failure
124
124
Fever
123
123
Complaint, Ill-Defined
121
121
Wound Dehiscence
118
118
Cardiac Arrest
117
117
Cardiac Tamponade
99
99
Fall
98
98
Pneumothorax
97
97
Cardiac Perforation
92
92
Swelling/ Edema
92
92
Arrhythmia
84
84
Syncope/Fainting
83
83
Swelling
80
80
Syncope
79
79
Purulent Discharge
69
69
Low Blood Pressure/ Hypotension
69
69
Ventricular Fibrillation
68
68
Congestive Heart Failure
65
65
Failure of Implant
64
64
Hiccups
61
61
Exit Block
61
61
Twitching
61
61
Palpitations
60
60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
59
59
Heart Failure/Congestive Heart Failure
58
58
Ventricular Tachycardia
56
56
Thrombosis
55
55
Twiddlers Syndrome
55
55
Pleural Effusion
54
54
Perforation
53
53
Bradycardia
53
53
Septic Shock
49
49
Tachycardia
48
48
Atrial Fibrillation
47
47
Shock from Patient Lead(s)
45
45
Obstruction/Occlusion
42
42
Weakness
42
42
Occlusion
40
40
Perforation of Vessels
37
37
Thrombosis/Thrombus
37
37
Fluid Discharge
36
36
Drug Resistant Bacterial Infection
36
36
No Information
35
35
Impaired Healing
31
31
Inflammation
31
31
Nausea
31
31
Muscle Weakness
30
30
Thrombus
30
30
Chills
26
26
Cardiomyopathy
23
23
Pneumonia
22
22
Vomiting
20
20
Cardiogenic Shock
20
20
Stenosis
19
19
Foreign Body In Patient
19
19
Asystole
19
19
Renal Failure
19
19
Hypersensitivity/Allergic reaction
17
17
Edema
17
17
Heart Block
17
17
Cardiopulmonary Arrest
16
16
Pulmonary Edema
16
16
Myocardial Infarction
15
15
Non specific EKG/ECG Changes
15
15
Malaise
15
15
Sleep Dysfunction
15
15
Loss of consciousness
14
14
Respiratory Failure
14
14
Necrosis
14
14
Muscle Spasm(s)
14
14
Staphylococcus Aureus
14
14
Pulmonary Embolism
13
13
Presyncope
13
13
Lethargy
12
12
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