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TPLC
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Device
implantable pacemaker pulse-generator
Product Code
DXY
Regulation Number
870.3610
Device Class
3
Premarket Approvals (PMA)
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
0
0
15
52
45
19
23
20
14
19
2
MDR Year
MDR Reports
MDR Events
2014
5603
5603
2015
1021
1021
2016
540
540
2017
1047
1047
2018
2071
2071
2019
1799
1799
2020
546
546
2021
560
560
2022
784
784
2023
947
947
2024
195
195
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
2482
2482
Pacemaker Found in Back-Up Mode
2161
2161
Over-Sensing
1439
1439
Device Dislodged or Dislocated
933
933
Device Operates Differently Than Expected
892
892
Premature Discharge of Battery
793
793
Failure to Capture
762
762
Signal Artifact/Noise
643
643
High Capture Threshold
561
561
Failure to Interrogate
550
550
High impedance
514
514
Pacing Problem
428
428
Under-Sensing
360
360
Connection Problem
348
348
Appropriate Term/Code Not Available
329
329
Device Sensing Problem
297
297
Low impedance
280
280
Device Displays Incorrect Message
278
278
Impedance Problem
277
277
Capturing Problem
276
276
Fracture
272
272
Difficult to Insert
269
269
Inappropriate/Inadequate Shock/Stimulation
255
255
Mechanical Problem
237
237
Break
237
237
Premature Elective Replacement Indicator
227
227
Failure to Sense
195
195
Telemetry Discrepancy
159
159
Incorrect Measurement
151
151
Battery Problem
140
140
No Pacing
138
138
Output Problem
134
134
No Device Output
126
126
Intermittent Capture
114
114
Data Problem
112
112
Insufficient Information
111
111
Decreased Sensitivity
105
105
Inappropriate or Unexpected Reset
85
85
Positioning Problem
80
80
Reset Problem
78
78
Difficult to Remove
74
74
Misconnection
74
74
Loose or Intermittent Connection
74
74
Unstable Capture Threshold
71
71
Failure to Disconnect
66
66
Communication or Transmission Problem
65
65
Nonstandard Device
63
63
Electrical /Electronic Property Problem
49
49
Defective Device
47
47
Sensing Intermittently
46
46
Incorrect, Inadequate or Imprecise Result or Readings
43
43
Invalid Sensing
42
42
Unable to Obtain Readings
40
40
Loss of Data
40
40
Material Integrity Problem
39
39
Premature End-of-Life Indicator
37
37
Low Sensing Threshold
37
37
Retraction Problem
36
36
Electromagnetic Interference
36
36
Difficult to Interrogate
35
35
Wireless Communication Problem
32
32
Out-Of-Box Failure
30
30
Pacing Inadequately
29
29
Activation, Positioning or Separation Problem
28
28
Ambient Noise Problem
28
28
Interrogation Problem
26
26
Programming Issue
25
25
Migration or Expulsion of Device
25
25
Positioning Failure
24
24
Use of Device Problem
24
24
Protective Measures Problem
20
20
Defibrillation/Stimulation Problem
18
18
Fitting Problem
17
17
Battery Problem: High Impedance
17
17
Battery Impedance Issue
15
15
No Apparent Adverse Event
15
15
Pacing Asynchronously
15
15
Degraded
14
14
Therapeutic or Diagnostic Output Failure
14
14
Device-Device Incompatibility
14
14
Electronic Property Issue
14
14
Migration
13
13
Display or Visual Feedback Problem
13
13
Pacing Intermittently
13
13
Separation Failure
12
12
Pocket Stimulation
12
12
Noise, Audible
12
12
Missing Test Results
12
12
Material Deformation
11
11
Contamination of Device Ingredient or Reagent
11
11
Detachment of Device or Device Component
10
10
High Sensing Threshold
10
10
Device Alarm System
10
10
Low Battery
9
9
Failure to Transmit Record
9
9
Material Twisted/Bent
9
9
Device Contamination with Body Fluid
8
8
Component Missing
8
8
Cut In Material
7
7
Inaccurate Synchronization
7
7
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
8470
8471
No Clinical Signs, Symptoms or Conditions
1546
1546
Unspecified Infection
1523
1523
Death
502
503
No Consequences Or Impact To Patient
270
270
Shock from Patient Lead(s)
245
245
Syncope
229
229
Insufficient Information
204
204
Muscle Stimulation
192
192
Dizziness
187
187
No Patient Involvement
169
169
Fatigue
165
165
Bradycardia
134
134
Dyspnea
133
133
Pericardial Effusion
130
130
Pocket Erosion
129
129
Cardiac Arrest
122
122
Discomfort
115
115
No Information
114
114
Arrhythmia
114
114
No Code Available
113
113
Cardiac Perforation
108
108
Chest Pain
107
107
Complaint, Ill-Defined
106
106
Hematoma
104
104
Pain
83
83
Pneumothorax
80
80
Cardiac Tamponade
79
79
Erosion
71
71
Syncope/Fainting
69
69
Endocarditis
68
68
Sepsis
67
67
Twiddlers Syndrome
63
63
Palpitations
60
60
Atrial Fibrillation
56
56
Ventricular Fibrillation
54
54
Ventricular Tachycardia
54
54
Undesired Nerve Stimulation
52
52
Swelling
49
49
Tachycardia
49
49
Fever
41
41
Fall
38
38
Bacterial Infection
35
35
Low Blood Pressure/ Hypotension
34
34
Complete Heart Block
34
34
Perforation
31
31
Heart Failure
30
30
Stroke/CVA
29
29
Wound Dehiscence
28
28
Hemothorax
25
25
Weakness
25
25
Exit Block
24
24
Pleural Effusion
23
23
Occlusion
23
23
Heart Failure/Congestive Heart Failure
21
21
Vascular Dissection
20
20
Electric Shock
20
20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
18
18
Myocardial Infarction
18
18
Inflammation
17
17
Septic Shock
17
17
Thrombosis
17
17
Device Overstimulation of Tissue
16
16
Failure of Implant
16
16
Fainting
16
16
Atrial Flutter
16
16
Hemorrhage/Bleeding
15
15
Nausea
15
15
Loss of consciousness
15
15
Asystole
14
14
Tricuspid Valve Insufficiency/ Regurgitation
14
14
Pulmonary Embolism
14
14
Chest Tightness/Pressure
13
13
Hypersensitivity/Allergic reaction
11
11
Non specific EKG/ECG Changes
11
11
Purulent Discharge
11
11
Staphylococcus Aureus
11
11
Thrombus
11
11
Twitching
10
10
Obstruction/Occlusion
10
10
Thrombosis/Thrombus
10
10
Heart Block
9
9
Edema
9
9
High Blood Pressure/ Hypertension
9
9
Chills
8
8
Shock
8
8
Post Operative Wound Infection
8
8
Malaise
8
8
Sudden Cardiac Death
8
8
Respiratory Failure
7
7
Blood Loss
7
7
Injury
7
7
Collapse
7
7
Swelling/ Edema
7
7
Presyncope
6
6
Cardiogenic Shock
6
6
Diminished Pulse Pressure
6
6
Foreign Body In Patient
6
6
Skin Irritation
6
6
Great Vessel Perforation
6
6
Recalls
Manufacturer
Recall Class
Date Posted
1
St Jude Medical Inc.
II
Jun-12-2018
2
St. Jude Medical, Cardiac Rhythm Management Division
II
Aug-02-2022
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