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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)
2020
2021
2022
2023
2024
2025
90
70
65
54
58
13
MDR Year
MDR Reports
MDR Events
2020
8989
8989
2021
9374
9374
2022
14287
14287
2023
12638
12638
2024
10500
10501
2025
2601
2601
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
15894
15895
Premature Discharge of Battery
13881
13881
Over-Sensing
5431
5431
Battery Problem
4378
4378
Incorrect, Inadequate or Imprecise Result or Readings
4232
4232
Defective Device
3975
3975
High impedance
3929
3929
Pacing Problem
3527
3527
Signal Artifact/Noise
3286
3286
Failure to Capture
2677
2677
High Capture Threshold
1902
1902
Under-Sensing
1614
1614
Failure to Interrogate
1388
1388
Low impedance
801
801
Device Dislodged or Dislocated
791
791
Noise, Audible
691
691
Failure to Read Input Signal
679
679
Inappropriate/Inadequate Shock/Stimulation
669
669
No Pacing
659
659
Incorrect Measurement
622
622
Device Displays Incorrect Message
612
612
Pacemaker Found in Back-Up Mode
610
610
Interrogation Problem
607
607
Connection Problem
577
577
Material Integrity Problem
522
522
No Apparent Adverse Event
418
418
Device Sensing Problem
393
393
Data Problem
391
391
Impedance Problem
361
361
Telemetry Discrepancy
327
327
Loose or Intermittent Connection
284
284
Off-Label Use
231
231
Pocket Stimulation
229
229
Inappropriate or Unexpected Reset
219
219
Insufficient Information
213
213
Inaccurate Synchronization
205
205
Migration
202
202
Pacing Asynchronously
199
199
Capturing Problem
188
188
Use of Device Problem
180
180
Positioning Problem
157
157
Difficult to Insert
140
140
Failure to Disconnect
135
135
Appropriate Term/Code Not Available
134
134
Unexpected Therapeutic Results
128
128
Fracture
119
119
Difficult to Remove
118
118
Mechanical Problem
113
113
Output Problem
112
112
Communication or Transmission Problem
108
108
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
35893
35893
Unspecified Infection
7189
7190
No Code Available
4264
4264
No Known Impact Or Consequence To Patient
3751
3751
Insufficient Information
2696
2696
No Consequences Or Impact To Patient
1653
1653
Sepsis
1218
1218
Pocket Erosion
1005
1005
Syncope/Fainting
990
990
Arrhythmia
740
740
Asystole
645
645
Dizziness
606
606
Discomfort
603
603
Electric Shock
537
537
Device Overstimulation of Tissue
520
520
Bradycardia
447
447
Bacterial Infection
321
321
Dyspnea
282
282
Fatigue
226
226
Pain
207
207
Hematoma
195
195
Shock from Patient Lead(s)
188
188
No Patient Involvement
184
184
Erosion
174
174
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
166
166
Wound Dehiscence
160
160
Fall
157
157
Unspecified Heart Problem
152
152
Syncope
133
133
Endocarditis
129
129
Atrial Fibrillation
128
128
Muscle Stimulation
116
116
Presyncope
113
113
Swelling/ Edema
105
105
Death
100
100
Chest Pain
95
95
No Information
93
93
Cardiac Arrest
89
89
Undesired Nerve Stimulation
88
88
Anxiety
87
87
Ventricular Fibrillation
87
87
Loss of consciousness
87
87
Tachycardia
78
78
Fever
72
72
Purulent Discharge
64
64
Malaise
58
58
Hypersensitivity/Allergic reaction
54
54
Heart Failure/Congestive Heart Failure
52
52
Twiddlers Syndrome
46
46
Low Blood Pressure/ Hypotension
46
46
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
I
Jan-10-2025
2
Boston Scientific Corporation
I
Jul-13-2021
3
Boston Scientific Corporation
II
Jul-02-2021
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