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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)
2018
2019
2020
2021
2022
2023
24
21
19
19
9
0
MDR Year
MDR Reports
MDR Events
2018
3979
3979
2019
3929
3929
2020
2776
2776
2021
2869
2869
2022
2954
2954
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
5156
5156
Device Dislodged or Dislocated
3709
3709
High Capture Threshold
2975
2975
Failure to Capture
2285
2285
High impedance
1228
1228
Capturing Problem
1004
1004
Activation, Positioning or Separation Problem
757
757
Low impedance
445
445
Positioning Problem
440
440
Appropriate Term/Code Not Available
437
437
Impedance Problem
394
394
Break
368
368
Fracture
322
322
Unstable Capture Threshold
226
226
Difficult to Insert
194
194
Intermittent Capture
186
186
Material Integrity Problem
166
166
Difficult to Remove
160
160
Over-Sensing
141
141
Pacing Problem
121
121
Ambient Noise Problem
111
111
Signal Artifact/Noise
97
97
Separation Failure
88
88
Therapy Delivered to Incorrect Body Area
81
81
Insufficient Information
73
73
Failure to Advance
51
51
Device Sensing Problem
48
48
Failure to Sense
47
47
Pocket Stimulation
42
42
Use of Device Problem
36
36
Electrical /Electronic Property Problem
36
36
Under-Sensing
33
33
Device Contamination with Body Fluid
30
30
Mechanical Problem
30
30
Connection Problem
28
28
Improper or Incorrect Procedure or Method
28
28
No Pacing
27
27
Stretched
27
27
Accessory Incompatible
22
22
High Sensing Threshold
20
20
Material Twisted/Bent
19
19
Detachment of Device or Device Component
19
19
Positioning Failure
15
15
Device Handling Problem
14
14
Defective Device
14
14
Device Operates Differently Than Expected
13
13
Material Split, Cut or Torn
12
12
Naturally Worn
11
11
Difficult to Advance
11
11
Loose or Intermittent Connection
11
11
Failure to Disconnect
11
11
Inappropriate/Inadequate Shock/Stimulation
10
10
Material Deformation
9
9
Retraction Problem
9
9
Malposition of Device
8
8
Physical Resistance/Sticking
8
8
Patient-Device Incompatibility
7
7
Pacing Inadequately
6
6
Migration
6
6
Device Contamination with Chemical or Other Material
6
6
Difficult To Position
6
6
Flushing Problem
5
5
No Apparent Adverse Event
5
5
Deformation Due to Compressive Stress
5
5
Low Sensing Threshold
5
5
Detachment Of Device Component
5
5
Material Separation
5
5
Device Damaged by Another Device
5
5
Human-Device Interface Problem
4
4
Migration or Expulsion of Device
4
4
Decreased Sensitivity
4
4
Difficult or Delayed Positioning
4
4
Premature Discharge of Battery
4
4
Difficult to Flush
4
4
Premature Activation
3
3
Microbial Contamination of Device
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Material Fragmentation
3
3
Bent
3
3
Misconnection
3
3
Device-Device Incompatibility
3
3
Fitting Problem
3
3
Unexpected Therapeutic Results
3
3
Loss of Threshold
2
2
Battery Problem
2
2
Contamination of Device Ingredient or Reagent
2
2
Peeled/Delaminated
2
2
Contamination
2
2
Inadequacy of Device Shape and/or Size
2
2
Product Quality Problem
2
2
Complete Blockage
2
2
Electromagnetic Interference
2
2
Material Too Rigid or Stiff
2
2
Material Protrusion/Extrusion
2
2
Device Markings/Labelling Problem
2
2
Device Displays Incorrect Message
2
2
Misassembled
2
2
Entrapment of Device
2
2
Material Erosion
2
2
Component Missing
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
5403
5403
No Clinical Signs, Symptoms or Conditions
3908
3908
Unspecified Infection
2942
2942
Undesired Nerve Stimulation
940
940
Muscle Stimulation
787
787
No Consequences Or Impact To Patient
750
750
Device Overstimulation of Tissue
430
430
Death
348
348
Dyspnea
214
214
Pocket Erosion
152
152
Endocarditis
146
146
Sepsis
141
141
Discomfort
140
140
Erosion
140
140
Twiddlers Syndrome
111
111
Pericardial Effusion
96
96
Bacterial Infection
82
82
Hematoma
79
79
Chest Pain
79
79
Fatigue
71
71
Vascular Dissection
70
70
Fever
69
69
Wound Dehiscence
68
68
Dizziness
65
65
Insufficient Information
61
61
Pain
59
59
Erythema
56
56
No Code Available
55
55
Cardiac Arrest
50
50
Pneumothorax
46
46
Cardiac Perforation
46
46
Arrhythmia
45
45
Swelling
45
45
Heart Failure
44
44
Complaint, Ill-Defined
44
44
Cardiac Tamponade
42
42
Swelling/ Edema
41
41
Syncope
38
38
Hiccups
36
36
Twitching
36
36
Syncope/Fainting
35
35
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
35
35
Fall
34
34
Heart Failure/Congestive Heart Failure
34
34
Low Blood Pressure/ Hypotension
32
32
Twiddlers Syndrome
30
30
No Information
30
30
Pleural Effusion
29
29
Septic Shock
28
28
Obstruction/Occlusion
26
26
Ventricular Fibrillation
26
26
Purulent Discharge
25
25
Palpitations
24
24
Congestive Heart Failure
22
22
Occlusion
22
22
Perforation
21
21
Tachycardia
21
21
Weakness
20
20
Thrombosis
20
20
Ventricular Tachycardia
20
20
Bradycardia
20
20
Inflammation
19
19
Chills
18
18
Fluid Discharge
18
18
Thrombosis/Thrombus
17
17
Impaired Healing
17
17
Perforation of Vessels
17
17
Muscle Weakness
16
16
Cardiogenic Shock
16
16
Drug Resistant Bacterial Infection
15
15
Exit Block
14
14
Non specific EKG/ECG Changes
13
13
Failure of Implant
12
12
Atrial Fibrillation
12
12
Thrombus
11
11
Sleep Dysfunction
11
11
Hypersensitivity/Allergic reaction
11
11
Nausea
11
11
Pulmonary Edema
10
10
Muscle Spasm(s)
10
10
Discharge
10
10
Cardiopulmonary Arrest
10
10
Pneumonia
10
10
Vomiting
9
9
Stenosis
9
9
High Blood Pressure/ Hypertension
9
9
Shock from Patient Lead(s)
9
9
Heart Block
9
9
Necrosis
8
8
Edema
8
8
Renal Failure
8
8
Therapeutic Effects, Unexpected
8
8
Abscess
8
8
Presyncope
7
7
Asystole
6
6
Hypoxia
6
6
Myocardial Infarction
6
6
Cellulitis
6
6
Malaise
6
6
Cardiomyopathy
6
6
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