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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)
2018
2019
2020
2021
2022
2023
97
88
90
70
65
37
MDR Year
MDR Reports
MDR Events
2018
14935
14935
2019
9627
9627
2020
8989
8989
2021
9374
9374
2022
14287
14287
2023
8876
8876
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
17153
17153
Premature Discharge of Battery
16836
16836
Device Displays Incorrect Message
5787
5787
High impedance
5705
5705
Over-Sensing
5018
5018
Battery Problem
3440
3440
Defective Device
3354
3354
Pacing Problem
3354
3354
Failure to Capture
2945
2945
Signal Artifact/Noise
2236
2236
Incorrect, Inadequate or Imprecise Result or Readings
1842
1842
Device Dislodged or Dislocated
1837
1837
Material Integrity Problem
1713
1713
High Capture Threshold
1598
1598
Pacemaker Found in Back-Up Mode
1578
1578
Device Sensing Problem
1337
1337
Ambient Noise Problem
1298
1298
Capturing Problem
1295
1295
Noise, Audible
1211
1211
Failure to Interrogate
1073
1073
Low impedance
1046
1046
Under-Sensing
999
999
Connection Problem
776
776
Inappropriate/Inadequate Shock/Stimulation
632
632
Device Operates Differently Than Expected
590
590
Impedance Problem
553
553
Incorrect Measurement
540
540
No Pacing
496
496
Data Problem
472
472
Device Alarm System
471
471
Interrogation Problem
430
430
Pocket Stimulation
408
408
Inappropriate or Unexpected Reset
355
355
Communication or Transmission Problem
329
329
Human-Device Interface Problem
299
299
Fracture
281
281
No Apparent Adverse Event
273
273
Failure to Read Input Signal
272
272
Use of Device Problem
262
262
Appropriate Term/Code Not Available
233
233
Telemetry Discrepancy
227
227
Off-Label Use
216
216
Migration
212
212
Output Problem
212
212
Loose or Intermittent Connection
211
211
Mechanical Problem
210
210
Positioning Problem
208
208
Insufficient Information
176
176
Difficult to Remove
170
170
Difficult to Insert
162
162
Electrical /Electronic Property Problem
161
161
Difficult To Position
158
158
Reset Problem
155
155
Break
152
152
Unexpected Therapeutic Results
147
147
Inaccurate Synchronization
145
145
No Display/Image
141
141
Misconnection
139
139
Operating System Version or Upgrade Problem
137
137
No Device Output
130
130
Failure to Sense
126
126
Wireless Communication Problem
119
119
Unexpected Shutdown
118
118
Pacing Asynchronously
117
117
Migration or Expulsion of Device
110
110
Patient-Device Incompatibility
105
105
Premature Elective Replacement Indicator
101
101
Failure to Convert Rhythm
94
94
Failure to Disconnect
90
90
False Positive Result
85
85
Display or Visual Feedback Problem
79
79
Intermittent Capture
74
74
Calibration Problem
73
73
Defibrillation/Stimulation Problem
64
64
Delayed Charge Time
59
59
Unable to Obtain Readings
58
58
Fitting Problem
51
51
Failure to Select Signal
49
49
Unstable Capture Threshold
46
46
Pacing Intermittently
42
42
Pacing Inadequately
40
40
Missing Test Results
39
39
Unintended Electrical Shock
38
38
Contamination /Decontamination Problem
37
37
Loss of Data
36
36
Battery Problem: High Impedance
36
36
Power Problem
36
36
Packaging Problem
36
36
Therapeutic or Diagnostic Output Failure
36
36
No Audible Alarm
35
35
Therapy Delivered to Incorrect Body Area
32
32
Failure to Power Up
29
29
Device Contamination With Biological Material
29
29
Electromagnetic Interference
27
27
Separation Failure
25
25
Contamination of Device Ingredient or Reagent
24
24
Program or Algorithm Execution Problem
23
23
Difficult to Interrogate
23
23
Nonstandard Device
22
22
Device Markings/Labelling Problem
22
22
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
24367
24367
No Known Impact Or Consequence To Patient
15552
15552
Unspecified Infection
8563
8563
No Consequences Or Impact To Patient
7038
7038
No Code Available
4431
4431
Sepsis
2287
2287
Insufficient Information
2153
2153
Pocket Erosion
1119
1119
Syncope
827
827
No Patient Involvement
730
730
Dizziness
619
619
Syncope/Fainting
575
575
Arrhythmia
472
472
Muscle Stimulation
471
471
Electric Shock
471
471
Discomfort
426
426
Death
422
422
Bradycardia
419
419
Asystole
343
343
Complaint, Ill-Defined
318
318
Bacterial Infection
310
310
No Information
304
304
Device Overstimulation of Tissue
287
287
Atrial Fibrillation
283
283
Erosion
269
269
Pain
263
263
Dyspnea
255
255
Fatigue
225
225
Cardiac Perforation
225
225
Hematoma
209
209
Endocarditis
193
193
Fall
190
190
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
153
153
Cardiac Arrest
147
147
Chest Pain
144
144
Wound Dehiscence
129
129
Ventricular Fibrillation
123
123
Staphylococcus Aureus
120
120
Twiddlers Syndrome
106
106
Pericardial Effusion
106
106
Undesired Nerve Stimulation
104
104
Fever
100
100
Ventricular Tachycardia
95
95
Palpitations
84
84
Tachycardia
74
74
Anxiety
73
73
Purulent Discharge
71
71
Swelling
68
68
Low Blood Pressure/ Hypotension
64
64
Complete Heart Block
57
57
Unspecified Heart Problem
55
55
Presyncope
54
54
Swelling/ Edema
53
53
Inflammation
53
53
Heart Failure
48
48
Hypersensitivity/Allergic reaction
45
45
Non specific EKG/ECG Changes
44
44
Loss of consciousness
41
41
Atrial Flutter
38
38
Twiddlers Syndrome
36
36
Fluid Discharge
33
33
Atrial Perforation
33
33
Malaise
32
32
Head Injury
31
31
Weakness
29
29
Nausea
28
28
Perforation
28
28
Cardiac Tamponade
28
28
Patient Problem/Medical Problem
28
28
Hemorrhage/Bleeding
27
27
Pneumothorax
26
26
Vascular Dissection
26
26
Heart Failure/Congestive Heart Failure
26
26
Discharge
23
23
Abscess
22
22
Stroke/CVA
22
22
Cardiomyopathy
19
19
Heart Block
19
19
Impaired Healing
18
18
High Blood Pressure/ Hypertension
18
18
Seizures
18
18
Muscle Weakness
18
18
Failure of Implant
17
17
Pleural Effusion
17
17
Septic Shock
17
17
Occlusion
17
17
Thrombosis
17
17
Burning Sensation
16
16
Cardiopulmonary Arrest
16
16
Post Operative Wound Infection
16
16
Obstruction/Occlusion
15
15
Atrial Tachycardia
15
15
Fainting
15
15
Myocardial Infarction
15
15
Headache
14
14
Bone Fracture(s)
14
14
Foreign Body In Patient
14
14
Implant Pain
13
13
Congestive Heart Failure
13
13
Itching Sensation
13
13
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
I
Jul-13-2021
2
Boston Scientific Corporation
II
Jul-02-2021
3
Boston Scientific Corporation
II
Jan-15-2018
4
St Jude Medical Inc.
II
Jun-12-2018
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