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TPLC
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Device
implantable pacemaker pulse-generator
Regulation Description
Implantable pacemaker pulse generator.
Product Code
DXY
Regulation Number
870.3610
Device Class
3
Premarket Approvals (PMA)
2020
2021
2022
2023
2024
2025
23
20
14
19
20
2
MDR Year
MDR Reports
MDR Events
2020
546
546
2021
560
560
2022
784
784
2023
948
948
2024
811
811
2025
78
78
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
729
729
Over-Sensing
368
368
Premature Discharge of Battery
338
338
Failure to Interrogate
194
194
Failure to Capture
179
179
Signal Artifact/Noise
179
179
Pacing Problem
178
178
Appropriate Term/Code Not Available
173
173
High Capture Threshold
154
154
High impedance
152
152
Under-Sensing
150
150
Impedance Problem
142
142
Pacemaker Found in Back-Up Mode
141
141
Inappropriate/Inadequate Shock/Stimulation
133
133
Device Dislodged or Dislocated
124
124
Fracture
100
100
No Pacing
99
99
Device Sensing Problem
97
97
Capturing Problem
93
93
Incorrect Measurement
87
87
Insufficient Information
73
73
Failure to Disconnect
72
72
Break
70
70
Low impedance
64
64
Loose or Intermittent Connection
64
64
Data Problem
58
58
Defective Device
53
53
Incorrect, Inadequate or Imprecise Result or Readings
51
51
Decreased Sensitivity
46
46
Battery Problem
45
45
Mechanical Problem
45
45
Electrical /Electronic Property Problem
43
43
Connection Problem
40
40
Difficult to Remove
38
38
Interrogation Problem
31
31
Positioning Problem
26
26
Misconnection
25
25
Unstable Capture Threshold
25
25
Output Problem
22
22
Intermittent Capture
20
20
Electromagnetic Interference
17
17
Inappropriate or Unexpected Reset
17
17
Communication or Transmission Problem
17
17
Material Integrity Problem
16
16
Use of Device Problem
15
15
No Apparent Adverse Event
14
14
Therapeutic or Diagnostic Output Failure
13
13
Display or Visual Feedback Problem
13
13
Wireless Communication Problem
12
12
Pacing Asynchronously
11
11
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1958
1958
Unspecified Infection
469
469
Insufficient Information
237
237
No Known Impact Or Consequence To Patient
199
199
No Consequences Or Impact To Patient
123
123
Shock from Patient Lead(s)
118
118
Arrhythmia
94
94
Syncope/Fainting
84
84
Dizziness
52
52
Cardiac Arrest
41
41
Discomfort
40
40
Pocket Erosion
40
40
Cardiac Tamponade
39
39
Dyspnea
38
38
Pneumothorax
37
37
Pericardial Effusion
37
37
Bradycardia
36
36
Heart Failure/Congestive Heart Failure
36
36
Sepsis
35
35
Cardiac Perforation
34
34
Bacterial Infection
32
32
Endocarditis
31
31
Tachycardia
29
29
Erosion
28
28
Hematoma
26
26
Death
25
25
Fatigue
23
23
No Code Available
22
22
Ventricular Fibrillation
21
21
Asystole
21
21
Pain
21
21
Tricuspid Valve Insufficiency/ Regurgitation
21
21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
20
20
Chest Pain
20
20
Electric Shock
20
20
Undesired Nerve Stimulation
19
19
Stroke/CVA
19
19
Hemothorax
17
17
Device Overstimulation of Tissue
17
17
Hemorrhage/Bleeding
17
17
Thrombosis/Thrombus
16
16
Obstruction/Occlusion
16
16
Failure of Implant
15
15
No Information
14
14
Perforation
14
14
Myocardial Infarction
14
14
Swelling/ Edema
13
13
Syncope
12
12
Heart Block
12
12
Atrial Fibrillation
11
11
Recalls
Manufacturer
Recall Class
Date Posted
1
St. Jude Medical, Cardiac Rhythm Management Division
II
Aug-02-2022
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