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TPLC
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Device
implantable pulse generator, pacemaker (non-crt)
Definition
These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Product Code
LWP
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
78
66
91
123
116
126
97
97
116
97
88
90
70
65
54
11
MDR Year
MDR Reports
MDR Events
2014
9399
9399
2015
9422
9422
2016
12356
12356
2017
11643
11643
2018
14937
14937
2019
9627
9627
2020
8989
8989
2021
9374
9374
2022
14287
14287
2023
12639
12639
2024
2700
2700
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
24729
24729
Premature Discharge of Battery
23908
23908
Device Displays Incorrect Message
12046
12046
High impedance
11444
11444
Over-Sensing
9330
9330
Pacing Problem
6350
6350
Failure to Capture
5937
5937
Pacemaker Found in Back-Up Mode
4515
4515
Device Operates Differently Than Expected
4289
4289
Battery Problem
4018
4018
Defective Device
3821
3821
Ambient Noise Problem
3186
3186
Device Dislodged or Dislocated
3165
3165
Device Sensing Problem
2939
2939
Signal Artifact/Noise
2874
2874
Incorrect, Inadequate or Imprecise Result or Readings
2733
2733
High Capture Threshold
2723
2723
Capturing Problem
2642
2642
Low impedance
2549
2549
Material Integrity Problem
2546
2546
Device Alarm System
2005
2005
Connection Problem
1967
1967
Under-Sensing
1890
1890
Failure to Interrogate
1867
1867
Appropriate Term/Code Not Available
1827
1827
Nonstandard Device
1710
1710
Mechanical Problem
1318
1318
Noise, Audible
1265
1265
Inappropriate/Inadequate Shock/Stimulation
1152
1152
Impedance Problem
1112
1112
Output Problem
833
833
Communication or Transmission Problem
767
767
Inappropriate or Unexpected Reset
753
753
Electrical /Electronic Property Problem
751
751
No Display/Image
727
727
No Device Output
711
711
Incorrect Measurement
697
697
Pocket Stimulation
692
692
No Pacing
663
663
Use of Device Problem
627
627
Data Problem
596
596
Telemetry Discrepancy
585
585
Interrogation Problem
529
529
Fracture
520
520
Break
437
437
Failure to Read Input Signal
432
432
Human-Device Interface Problem
424
424
Insufficient Information
401
401
Power Problem
388
388
Positioning Problem
381
381
No Apparent Adverse Event
361
361
Premature Elective Replacement Indicator
332
332
Operating System Version or Upgrade Problem
318
318
Loose or Intermittent Connection
314
314
Difficult to Remove
304
304
Difficult To Position
301
301
Reset Problem
299
299
Failure to Sense
266
266
Defibrillation/Stimulation Problem
257
257
Difficult to Insert
253
253
Migration or Expulsion of Device
252
252
Off-Label Use
247
247
Migration
229
229
Failure of Device to Self-Test
192
192
Device Contamination with Chemical or Other Material
188
188
Fitting Problem
175
175
Inaccurate Synchronization
171
171
Unexpected Therapeutic Results
168
168
Intermittent Capture
168
168
Wireless Communication Problem
165
165
Programming Issue
159
159
Failure to Convert Rhythm
158
158
Pacing Asynchronously
154
154
Misconnection
146
146
Calibration Problem
131
131
Failure to Power Up
128
128
Failure to Disconnect
120
120
Unexpected Shutdown
120
120
Contamination
109
109
Unable to Obtain Readings
107
107
Patient-Device Incompatibility
106
106
Unstable Capture Threshold
100
100
Crack
92
92
False Positive Result
91
91
Pacing Inadequately
91
91
Display or Visual Feedback Problem
89
89
Difficult to Interrogate
87
87
Component Missing
84
84
Pacing Intermittently
83
83
No Audible Alarm
81
81
Sensing Intermittently
79
79
Device Contamination With Biological Material
72
72
Improper Alarm
71
71
Delayed Charge Time
71
71
Missing Test Results
68
68
Loss of Data
61
61
Improper Device Output
60
60
Battery Problem: High Impedance
58
58
Contamination /Decontamination Problem
58
58
Protective Measures Problem
56
56
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
34794
34794
No Clinical Signs, Symptoms or Conditions
29009
29009
No Consequences Or Impact To Patient
17827
17827
Unspecified Infection
13578
13578
No Code Available
4683
4683
No Patient Involvement
3528
3528
Sepsis
3055
3055
Insufficient Information
2404
2404
Syncope
2011
2011
Pocket Erosion
1643
1643
Dizziness
1246
1246
Death
1227
1227
Complaint, Ill-Defined
1125
1126
Muscle Stimulation
1111
1111
Bradycardia
760
760
Syncope/Fainting
743
743
Cardiac Arrest
735
735
Arrhythmia
706
706
Atrial Fibrillation
633
633
Discomfort
624
624
Electric Shock
554
554
Erosion
535
535
Dyspnea
527
527
Fatigue
511
511
Pain
476
477
Asystole
462
462
No Information
458
458
Bacterial Infection
427
427
Endocarditis
401
401
Fall
392
392
Device Overstimulation of Tissue
391
391
Hematoma
374
374
Ventricular Tachycardia
354
354
Cardiac Perforation
313
313
Staphylococcus Aureus
292
292
Ventricular Fibrillation
265
265
Undesired Nerve Stimulation
256
256
Chest Pain
255
255
Palpitations
204
204
Twiddlers Syndrome
178
178
Wound Dehiscence
177
177
Pericardial Effusion
172
172
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
161
161
Fever
159
159
Heart Failure
156
156
Tachycardia
139
139
Swelling
126
126
Complete Heart Block
118
118
Purulent Discharge
113
113
Atrial Flutter
109
109
Low Blood Pressure/ Hypotension
107
107
Patient Problem/Medical Problem
98
98
Anxiety
94
94
Inflammation
90
90
Unspecified Heart Problem
87
87
Presyncope
80
80
Swelling/ Edema
73
73
Loss of consciousness
70
70
Hypersensitivity/Allergic reaction
68
68
Atrial Tachycardia
62
62
Weakness
59
59
Cardiac Tamponade
57
57
Fainting
56
56
Non specific EKG/ECG Changes
54
54
Vascular Dissection
54
54
Pneumothorax
51
51
Nausea
48
48
Congestive Heart Failure
48
48
Twitching
47
47
Post Operative Wound Infection
46
46
Malaise
46
46
Atrial Perforation
45
45
Stroke/CVA
45
45
Head Injury
44
44
Perforation
43
43
Fluid Discharge
43
43
Shock from Patient Lead(s)
42
42
Heart Failure/Congestive Heart Failure
42
42
Hemorrhage/Bleeding
42
42
High Blood Pressure/ Hypertension
40
40
Twiddlers Syndrome
40
40
Cardiopulmonary Arrest
38
38
Burning Sensation
37
37
Cardiomyopathy
36
36
Respiratory Failure
35
35
Exit Block
34
34
Occlusion
34
34
Seizures
33
33
Cancer
33
33
Impaired Healing
32
32
Discharge
32
32
Pleural Effusion
31
31
Pneumonia
30
30
Septic Shock
30
30
Thrombosis
29
29
Perforation of Vessels
29
29
Abscess
28
28
Myocardial Infarction
27
27
Failure of Implant
26
26
Renal Failure
24
24
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific CRM Corp
II
Oct-18-2014
2
Boston Scientific CRM Corp
II
Oct-17-2013
3
Boston Scientific CRM Corp
II
Oct-07-2010
4
Boston Scientific CRM Corp
II
May-08-2010
5
Boston Scientific CRM Corp
II
Jan-13-2010
6
Boston Scientific CRM Corp
II
Aug-18-2009
7
Boston Scientific CRM Corp
II
Jul-17-2009
8
Boston Scientific CRM Corp
II
Jul-14-2009
9
Boston Scientific Corporation
I
Jul-13-2021
10
Boston Scientific Corporation
II
Jul-02-2021
11
Boston Scientific Corporation
II
Jan-15-2018
12
Boston Scientific Corporation
II
Dec-30-2016
13
Boston Scientific Corporation
II
Sep-07-2016
14
Medtronic Inc. Cardiac Rhythm Disease Management
II
May-24-2014
15
Medtronic Inc. Cardiac Rhythm Disease Managment
II
Nov-22-2010
16
St Jude Medical Inc.
II
Jun-12-2018
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