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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)
2018
2019
2020
2021
2022
2023
142
98
125
111
91
32
MDR Year
MDR Reports
MDR Events
2018
17238
17238
2019
16189
16189
2020
16912
16912
2021
19675
19675
2022
23504
23504
2023
7803
7803
Device Problems
MDRs with this Device Problem
Events in those MDRs
Over-Sensing
24075
24075
High impedance
17619
17619
Adverse Event Without Identified Device or Use Problem
16678
16678
Premature Discharge of Battery
13179
13179
Inappropriate/Inadequate Shock/Stimulation
12154
12154
Signal Artifact/Noise
11369
11369
Fracture
8131
8131
High Capture Threshold
5673
5673
Impedance Problem
5595
5595
Battery Problem
5045
5045
Device Sensing Problem
4868
4868
Under-Sensing
3218
3218
Low impedance
2981
2981
Pacing Problem
2904
2904
Incorrect, Inadequate or Imprecise Result or Readings
2717
2717
Failure to Read Input Signal
2651
2651
Device Dislodged or Dislocated
2559
2559
Failure to Capture
2345
2345
Defective Device
1889
1889
Decreased Sensitivity
1862
1862
Capturing Problem
1802
1802
Premature Elective Replacement Indicator
1555
1555
Device Displays Incorrect Message
1292
1292
Inappropriate or Unexpected Reset
1198
1198
Break
1130
1130
Mechanical Problem
1066
1066
Appropriate Term/Code Not Available
1031
1031
Noise, Audible
949
949
Material Integrity Problem
930
930
Failure to Convert Rhythm
916
916
Electrical /Electronic Property Problem
904
904
Failure to Interrogate
840
840
Electromagnetic Interference
793
793
Ambient Noise Problem
757
757
Connection Problem
736
736
Data Problem
681
681
Positioning Failure
657
657
Defibrillation/Stimulation Problem
605
605
Activation, Positioning or Separation Problem
568
568
Positioning Problem
536
536
Unstable Capture Threshold
472
472
Interrogation Problem
452
452
Communication or Transmission Problem
444
444
Delayed Charge Time
444
444
Device Alarm System
441
441
Device Operates Differently Than Expected
437
437
Premature End-of-Life Indicator
430
430
Migration
389
389
Failure to Deliver Shock/Stimulation
386
386
Inaccurate Synchronization
382
382
Failure to Charge
378
378
No Apparent Adverse Event
354
354
Failure to Select Signal
320
320
Unexpected Therapeutic Results
289
289
Incorrect Interpretation of Signal
276
276
Reset Problem
254
254
Invalid Sensing
240
240
Migration or Expulsion of Device
220
220
Use of Device Problem
218
218
Difficult to Remove
215
215
Telemetry Discrepancy
210
210
Insufficient Information
208
208
Patient-Device Incompatibility
200
200
Protective Measures Problem
191
191
Misconnection
189
189
Intermittent Capture
189
189
Unable to Obtain Readings
156
156
Failure to Sense
146
146
Loose or Intermittent Connection
144
144
Incorrect Measurement
130
130
Nonstandard Device
120
120
Material Twisted/Bent
104
104
Environmental Compatibility Problem
101
101
Power Problem
98
98
Human-Device Interface Problem
96
96
Off-Label Use
85
85
Difficult to Insert
84
84
Device-Device Incompatibility
84
84
No Audible Alarm
82
82
Output Problem
78
78
Pocket Stimulation
73
73
Collapse
72
72
Device Contamination with Body Fluid
64
64
Unintended Electrical Shock
58
58
Stretched
48
48
Pacing Asynchronously
47
47
Missing Test Results
47
47
No Pacing
47
47
Device Contamination with Chemical or Other Material
46
46
Material Deformation
44
44
Charging Problem
41
41
High Sensing Threshold
41
41
Low Sensing Threshold
37
37
Energy Output Problem
36
36
Wireless Communication Problem
36
36
Premature Activation
33
33
Detachment of Device or Device Component
31
31
Contamination /Decontamination Problem
30
30
Difficult to Fold, Unfold or Collapse
30
30
Improper or Incorrect Procedure or Method
29
29
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
35517
35517
No Known Impact Or Consequence To Patient
25261
25261
Unspecified Infection
13114
13114
No Consequences Or Impact To Patient
7343
7343
Electric Shock
5235
5235
Shock from Patient Lead(s)
4867
4867
No Code Available
3632
3632
Sepsis
2286
2286
Insufficient Information
1181
1181
Pocket Erosion
1127
1127
Death
813
813
Ventricular Fibrillation
686
686
Pain
658
658
Erosion
625
625
Discomfort
566
566
Syncope
554
554
Dizziness
529
529
Hematoma
521
521
Therapeutic Effects, Unexpected
521
521
Arrhythmia
511
511
No Patient Involvement
479
479
Syncope/Fainting
466
466
Endocarditis
466
466
Bradycardia
449
449
Bacterial Infection
402
402
Ventricular Tachycardia
402
402
Cardiac Perforation
385
385
Dyspnea
384
384
Chest Pain
382
382
Cardiac Arrest
367
367
Tachycardia
322
322
Pericardial Effusion
306
306
Wound Dehiscence
288
288
Complaint, Ill-Defined
273
273
Twiddlers Syndrome
249
249
Anxiety
241
241
Perforation
234
234
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
217
217
Fall
214
214
Fever
207
207
Atrial Fibrillation
204
204
Twiddlers Syndrome
203
203
Purulent Discharge
172
172
No Information
167
167
Muscle Stimulation
165
165
Swelling/ Edema
164
164
Staphylococcus Aureus
155
155
Cardiac Tamponade
147
147
Distress
145
145
Swelling
141
141
Asystole
141
141
Occlusion
139
139
Depression
138
138
Obstruction/Occlusion
129
129
Device Overstimulation of Tissue
122
122
Fatigue
110
110
Undesired Nerve Stimulation
109
109
Low Blood Pressure/ Hypotension
107
107
Emotional Changes
104
104
Fluid Discharge
102
102
Pneumothorax
91
91
Hypersensitivity/Allergic reaction
88
88
Impaired Healing
82
82
Inflammation
79
79
Erythema
79
79
Non specific EKG/ECG Changes
77
77
Palpitations
75
75
Failure of Implant
70
70
Thrombosis/Thrombus
69
69
Septic Shock
61
61
Loss of consciousness
56
56
Thrombosis
55
55
Chills
50
50
Weakness
48
48
Nausea
48
48
Muscle Weakness
47
47
Pleural Effusion
47
47
Heart Failure/Congestive Heart Failure
47
47
Drug Resistant Bacterial Infection
47
47
Shock
45
45
Heart Failure
42
42
Abscess
41
41
Patient Problem/Medical Problem
40
40
Presyncope
39
39
Vomiting
39
39
Heart Block
37
37
Stroke/CVA
34
34
Hemorrhage/Bleeding
34
34
Necrosis
33
33
Vascular Dissection
31
31
Implant Pain
28
28
Atrial Tachycardia
27
27
Cardiogenic Shock
26
26
Unspecified Heart Problem
26
26
Discharge
25
25
Bruise/Contusion
25
25
Stenosis
24
24
Burning Sensation
24
24
Perforation of Vessels
23
23
Injury
23
23
Recalls
Manufacturer
Recall Class
Date Posted
1
BIOTRONIK Inc
II
Apr-21-2021
2
Boston Scientific Corporation
II
Mar-03-2023
3
Boston Scientific Corporation
II
Sep-02-2022
4
Boston Scientific Corporation
II
Feb-18-2021
5
Boston Scientific Corporation
I
Feb-05-2021
6
Boston Scientific Corporation
I
Jan-19-2021
7
Boston Scientific Corporation
II
Oct-31-2020
8
Boston Scientific Corporation
II
Mar-03-2020
9
Boston Scientific Corporation
II
Sep-13-2019
10
Boston Scientific Corporation
II
Nov-16-2018
11
Boston Scientific Corporation
II
Sep-27-2018
12
Boston Scientific Corporation
II
Sep-27-2018
13
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
I
Aug-09-2022
14
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
II
Jun-14-2022
15
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
I
Mar-27-2021
16
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
II
Jul-10-2018
17
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
I
Feb-01-2018
18
St Jude Medical Inc.
I
Aug-02-2019
19
St Jude Medical Inc.
II
Jun-29-2018
20
St. Jude Medical, Cardiac Rhythm Management Division
II
Apr-21-2022
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