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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)
2020
2021
2022
2023
2024
2025
125
111
91
101
108
32
MDR Year
MDR Reports
MDR Events
2020
16909
16909
2021
19656
19656
2022
23461
23461
2023
28722
28722
2024
25242
25243
2025
5802
5802
Device Problems
MDRs with this Device Problem
Events in those MDRs
Over-Sensing
28938
28938
High impedance
18197
18197
Inappropriate/Inadequate Shock/Stimulation
18059
18059
Premature Discharge of Battery
17662
17662
Adverse Event Without Identified Device or Use Problem
17486
17486
Signal Artifact/Noise
15154
15154
Fracture
7916
7916
Incorrect, Inadequate or Imprecise Result or Readings
7108
7108
Impedance Problem
6631
6631
High Capture Threshold
6191
6191
Device Sensing Problem
6044
6044
Failure to Read Input Signal
5436
5436
Battery Problem
5171
5171
Pacing Problem
5130
5130
Under-Sensing
4906
4906
Low impedance
3661
3661
Device Dislodged or Dislocated
2607
2607
Failure to Capture
2521
2521
Premature Elective Replacement Indicator
2497
2498
Defective Device
2488
2488
Decreased Sensitivity
2253
2253
Capturing Problem
1811
1811
Noise, Audible
1606
1606
Failure to Convert Rhythm
1266
1266
Appropriate Term/Code Not Available
1249
1249
Break
1057
1057
Data Problem
1026
1026
Inappropriate or Unexpected Reset
1000
1000
Mechanical Problem
998
998
Electromagnetic Interference
927
927
Electrical /Electronic Property Problem
838
838
Failure to Interrogate
770
770
Inaccurate Synchronization
764
764
Connection Problem
758
758
Defibrillation/Stimulation Problem
713
713
Failure to Deliver Shock/Stimulation
707
707
Material Integrity Problem
696
696
Premature End-of-Life Indicator
635
635
Interrogation Problem
632
632
Positioning Problem
604
604
Insufficient Information
588
588
Migration
559
559
No Apparent Adverse Event
542
542
Unstable Capture Threshold
532
532
Activation, Positioning or Separation Problem
475
475
Unexpected Therapeutic Results
404
404
Positioning Failure
389
389
Use of Device Problem
370
370
Nonstandard Device
360
360
Incorrect Interpretation of Signal
350
350
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
65753
65754
Unspecified Infection
14124
14124
Shock from Patient Lead(s)
9392
9392
Electric Shock
7935
7935
No Known Impact Or Consequence To Patient
5189
5189
No Consequences Or Impact To Patient
4556
4556
Insufficient Information
3761
3761
No Code Available
3334
3334
Sepsis
1857
1857
Pocket Erosion
1146
1146
Discomfort
1071
1071
Arrhythmia
999
999
Syncope/Fainting
985
985
Ventricular Fibrillation
912
912
Pain
870
870
Bacterial Infection
773
773
Tachycardia
768
768
Bradycardia
715
715
Erosion
686
686
Dizziness
621
621
Chest Pain
552
552
Swelling/ Edema
506
506
Hematoma
494
494
Endocarditis
471
471
Dyspnea
457
457
Wound Dehiscence
448
448
Purulent Discharge
448
448
Erythema
437
437
Cardiac Arrest
437
437
Cardiac Perforation
397
397
Fever
391
391
Twiddlers Syndrome
355
355
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
338
338
Asystole
335
335
Pericardial Effusion
311
311
Foreign Body In Patient
267
267
Fall
242
242
Perforation
241
241
Obstruction/Occlusion
240
240
Device Overstimulation of Tissue
205
205
Fluid Discharge
196
196
Failure of Implant
188
188
Atrial Fibrillation
168
168
Death
166
166
Low Blood Pressure/ Hypotension
165
165
Syncope
154
154
Drug Resistant Bacterial Infection
152
152
Anxiety
150
150
No Patient Involvement
143
143
Cardiac Tamponade
141
141
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
Medtronic Inc.
II
Jun-26-2024
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, Cardiac Rhythm Management Division
II
Apr-21-2022
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