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Device
implantable cardioverter defibrillator (non-crt)
Definition
These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.
Product Code
LWS
Device Class
3
Premarket Approvals (PMA)
2019
2020
2021
2022
2023
2024
98
125
111
91
101
16
MDR Year
MDR Reports
MDR Events
2019
16186
16186
2020
16910
16910
2021
19659
19659
2022
23463
23463
2023
28724
28724
2024
4284
4284
Device Problems
MDRs with this Device Problem
Events in those MDRs
Over-Sensing
25785
25785
High impedance
17574
17574
Adverse Event Without Identified Device or Use Problem
17052
17052
Premature Discharge of Battery
15227
15227
Inappropriate/Inadequate Shock/Stimulation
14450
14450
Signal Artifact/Noise
13126
13126
Fracture
7978
7978
Impedance Problem
6170
6170
High Capture Threshold
6038
6038
Device Sensing Problem
5534
5534
Battery Problem
5095
5095
Incorrect, Inadequate or Imprecise Result or Readings
4875
4875
Failure to Read Input Signal
3991
3991
Under-Sensing
3973
3973
Pacing Problem
3648
3648
Low impedance
3257
3257
Device Dislodged or Dislocated
2670
2670
Failure to Capture
2420
2420
Defective Device
2242
2242
Decreased Sensitivity
2059
2059
Premature Elective Replacement Indicator
1948
1948
Capturing Problem
1686
1686
Noise, Audible
1291
1291
Break
1078
1078
Failure to Convert Rhythm
1064
1064
Inappropriate or Unexpected Reset
1033
1033
Appropriate Term/Code Not Available
1031
1031
Mechanical Problem
994
994
Electromagnetic Interference
892
892
Material Integrity Problem
875
875
Data Problem
839
839
Electrical /Electronic Property Problem
831
831
Failure to Interrogate
747
747
Connection Problem
744
744
Defibrillation/Stimulation Problem
584
584
Interrogation Problem
579
579
Positioning Problem
576
576
Insufficient Information
563
563
Inaccurate Synchronization
547
547
Failure to Deliver Shock/Stimulation
546
546
Premature End-of-Life Indicator
515
515
Unstable Capture Threshold
507
507
Positioning Failure
506
506
Migration
500
500
No Apparent Adverse Event
483
483
Activation, Positioning or Separation Problem
476
476
Unexpected Therapeutic Results
370
370
Delayed Charge Time
365
365
Nonstandard Device
364
364
Failure to Charge
337
337
Use of Device Problem
322
322
Incorrect Interpretation of Signal
299
299
Therapeutic or Diagnostic Output Failure
293
293
Failure to Select Signal
292
292
Device Displays Incorrect Message
237
237
Communication or Transmission Problem
237
237
Reset Problem
234
234
Telemetry Discrepancy
230
230
Device Alarm System
225
225
Difficult to Remove
214
214
Patient-Device Incompatibility
193
193
Intermittent Capture
188
188
Migration or Expulsion of Device
174
174
Environmental Compatibility Problem
174
174
Misconnection
172
172
Unable to Obtain Readings
152
152
Incorrect Measurement
147
147
Protective Measures Problem
147
147
Loose or Intermittent Connection
137
137
Failure to Sense
132
132
Power Problem
129
129
Material Twisted/Bent
119
119
Off-Label Use
113
113
Output Problem
96
96
No Audible Alarm
94
94
Difficult to Insert
88
88
Device-Device Incompatibility
79
79
No Pacing
78
78
Pocket Stimulation
66
66
Human-Device Interface Problem
65
65
Pacing Asynchronously
63
63
Device Contamination with Body Fluid
61
61
Collapse
60
60
Product Quality Problem
57
57
Unintended Electrical Shock
55
55
Missing Test Results
51
51
Device Contamination with Chemical or Other Material
47
47
Stretched
45
45
Defective Component
45
45
High Sensing Threshold
40
40
Ambient Noise Problem
39
39
Premature Activation
39
39
Difficult to Fold, Unfold or Collapse
38
38
Compatibility Problem
36
36
Material Deformation
36
36
Energy Output Problem
35
35
Contamination /Decontamination Problem
32
32
Detachment of Device or Device Component
29
29
Charging Problem
29
29
Low Sensing Threshold
29
29
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
49488
49488
No Known Impact Or Consequence To Patient
15071
15071
Unspecified Infection
13836
13836
Electric Shock
7817
7817
No Consequences Or Impact To Patient
5410
5410
Shock from Patient Lead(s)
5395
5395
Insufficient Information
3532
3532
No Code Available
3469
3469
Sepsis
2085
2085
Pocket Erosion
1147
1147
Ventricular Fibrillation
751
751
Discomfort
736
736
Arrhythmia
730
730
Pain
715
715
Syncope/Fainting
709
709
Erosion
625
625
Dizziness
558
558
Bradycardia
548
548
Bacterial Infection
546
546
Tachycardia
513
513
Hematoma
498
498
Endocarditis
456
456
Death
443
443
Chest Pain
442
442
Dyspnea
405
405
Cardiac Perforation
404
404
Cardiac Arrest
374
374
Wound Dehiscence
345
345
Syncope
342
342
Pericardial Effusion
306
306
Swelling/ Edema
294
294
Twiddlers Syndrome
279
279
No Patient Involvement
277
277
Therapeutic Effects, Unexpected
273
273
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
272
272
Foreign Body In Patient
256
256
Perforation
254
254
Purulent Discharge
250
250
Fever
247
247
Asystole
244
244
Ventricular Tachycardia
224
224
Fall
219
219
Obstruction/Occlusion
180
180
Twiddlers Syndrome
177
177
Erythema
173
173
Atrial Fibrillation
162
162
Device Overstimulation of Tissue
160
160
Fluid Discharge
151
151
Cardiac Tamponade
140
140
Low Blood Pressure/ Hypotension
130
130
Undesired Nerve Stimulation
127
127
Anxiety
123
123
Complaint, Ill-Defined
116
116
Failure of Implant
108
108
Hypersensitivity/Allergic reaction
102
102
Emotional Changes
100
100
Muscle Stimulation
99
99
Staphylococcus Aureus
97
97
Impaired Healing
97
97
Fatigue
96
96
Thrombosis/Thrombus
95
95
Swelling
88
88
Heart Failure/Congestive Heart Failure
85
85
Occlusion
82
82
Drug Resistant Bacterial Infection
79
79
Loss of consciousness
78
78
Non specific EKG/ECG Changes
77
77
Pneumothorax
76
76
Presyncope
76
76
No Information
75
75
Muscle Weakness
72
72
Inflammation
70
70
Septic Shock
67
67
Heart Block
57
57
Chills
56
56
Palpitations
48
48
Nausea
47
47
Hemorrhage/Bleeding
47
47
Abscess
47
47
Shock
46
46
Vomiting
45
45
Pleural Effusion
44
44
Unspecified Heart Problem
43
43
Implant Pain
43
43
Weight Changes
42
42
Stroke/CVA
36
36
Vascular Dissection
35
35
Burning Sensation
35
35
Thrombosis
32
32
Skin Inflammation/ Irritation
30
30
Weakness
28
28
Necrosis
27
27
Bruise/Contusion
26
26
Cardiogenic Shock
24
24
Calcium Deposits/Calcification
23
23
Tricuspid Valve Insufficiency/ Regurgitation
23
23
Cellulitis
22
22
Pneumonia
22
22
Perforation of Vessels
22
22
Stenosis
20
20
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Medical
II
Sep-19-2023
2
BIOTRONIK Inc
II
Apr-21-2021
3
Boston Scientific Corporation
II
Jan-05-2024
4
Boston Scientific Corporation
II
Aug-22-2023
5
Boston Scientific Corporation
II
Mar-03-2023
6
Boston Scientific Corporation
II
Sep-02-2022
7
Boston Scientific Corporation
II
Feb-18-2021
8
Boston Scientific Corporation
I
Feb-05-2021
9
Boston Scientific Corporation
I
Jan-19-2021
10
Boston Scientific Corporation
II
Oct-31-2020
11
Boston Scientific Corporation
II
Mar-03-2020
12
Boston Scientific Corporation
II
Sep-13-2019
13
Medtronic Inc.
II
Jan-22-2024
14
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
I
Jun-16-2023
15
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
I
Aug-09-2022
16
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
II
Jun-14-2022
17
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
I
Mar-27-2021
18
St Jude Medical Inc.
I
Aug-02-2019
19
St. Jude Medical, Cardiac Rhythm Management Division
II
Apr-21-2022
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