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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implantable cardioverter defibrillator (non-crt)
Definition These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.
Product CodeLWS
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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