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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)
2021 2022 2023 2024 2025 2026
111 91 101 108 97 5

MDR Year MDR Reports MDR Events
2021 19655 19669
2022 23454 23484
2023 28703 28737
2024 25203 25223
2025 24634 24634

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 29909 29932
Inappropriate/Inadequate Shock/Stimulation 19420 19430
High impedance 18506 18524
Premature Discharge of Battery 17942 17948
Adverse Event Without Identified Device or Use Problem 16823 16839
Signal Artifact/Noise 15603 15612
Incorrect, Inadequate or Imprecise Result or Readings 7969 7969
Fracture 7259 7263
Impedance Problem 6753 6761
Device Sensing Problem 6373 6378
Failure to Read Input Signal 6049 6050
Pacing Problem 5990 5998
High Capture Threshold 5897 5902
Under-Sensing 5322 5329
Battery Problem 4999 5001
Low impedance 3729 3731
Premature Elective Replacement Indicator 2761 2764
Failure to Capture 2492 2499
Defective Device 2475 2481
Device Dislodged or Dislocated 2346 2349
Decreased Sensitivity 2149 2152
Capturing Problem 1789 1791
Noise, Audible 1697 1697
Appropriate Term/Code Not Available 1455 1458
Failure to Convert Rhythm 1409 1411
Inappropriate or Unexpected Reset 1084 1084
Data Problem 979 980
Break 975 977
Mechanical Problem 917 917
Electromagnetic Interference 905 906
Defibrillation/Stimulation Problem 885 886
Inaccurate Synchronization 826 826
Failure to Deliver Shock/Stimulation 783 783
Failure to Interrogate 756 756
Connection Problem 710 711
Premature End-of-Life Indicator 704 704
Electrical /Electronic Property Problem 702 703
Insufficient Information 674 675
Interrogation Problem 666 667
Material Integrity Problem 621 622
Migration 605 605
Positioning Problem 562 562
Unstable Capture Threshold 496 496
No Apparent Adverse Event 466 471
Use of Device Problem 438 439
Activation, Positioning or Separation Problem 429 429
Unexpected Therapeutic Results 422 422
Nonstandard Device 381 381
Incorrect Interpretation of Signal 373 374
Environmental Compatibility Problem 350 350

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 75609 75676
Unspecified Infection 13187 13193
Shock from Patient Lead(s) 12056 12061
Electric Shock 7044 7047
Insufficient Information 3890 3892
Sepsis 1484 1484
Discomfort 1242 1243
Arrhythmia 1162 1165
Syncope/Fainting 1110 1112
Pocket Erosion 1085 1087
Ventricular Fibrillation 1020 1021
Tachycardia 955 957
Pain 946 947
No Code Available 946 946
Bacterial Infection 881 881
Bradycardia 725 726
Swelling/ Edema 652 653
Erosion 647 648
Dizziness 631 633
Erythema 627 628
Chest Pain 586 587
Purulent Discharge 559 559
Wound Dehiscence 498 498
Dyspnea 475 476
No Known Impact Or Consequence To Patient 457 457
Hematoma 450 451
Endocarditis 443 445
Fever 441 441
Cardiac Arrest 440 442
Twiddlers Syndrome 388 388
Asystole 387 387
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 382 383
Cardiac Perforation 354 355
Pericardial Effusion 283 283
Foreign Body In Patient 270 271
Obstruction/Occlusion 270 271
No Consequences Or Impact To Patient 264 264
Fall 235 235
Device Overstimulation of Tissue 223 223
Failure of Implant 222 225
Fluid Discharge 219 219
Perforation 218 218
Drug Resistant Bacterial Infection 211 211
Low Blood Pressure/ Hypotension 176 176
Anxiety 175 176
Atrial Fibrillation 171 172
Heart Failure/Congestive Heart Failure 162 163
Hypersensitivity/Allergic reaction 153 153
Presyncope 149 149
Impaired Healing 129 129

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical II Sep-19-2023
2 BIOTRONIK Inc II Apr-21-2021
3 Boston Scientific Corporation I Oct-10-2025
4 Boston Scientific Corporation I Aug-20-2025
5 Boston Scientific Corporation II Jan-05-2024
6 Boston Scientific Corporation II Aug-22-2023
7 Boston Scientific Corporation II Mar-03-2023
8 Boston Scientific Corporation II Sep-02-2022
9 Boston Scientific Corporation II Feb-18-2021
10 Boston Scientific Corporation I Feb-05-2021
11 Boston Scientific Corporation I Jan-19-2021
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 Medtronic, Inc. II Nov-28-2025
19 St. Jude Medical, Cardiac Rhythm Management Division II Apr-21-2022
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