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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 80

MDR Year MDR Reports MDR Events
2021 19652 19666
2022 23452 23482
2023 28700 28734
2024 25195 25215
2025 24629 24629
2026 15551 15554

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 34680 34704
Inappropriate/Inadequate Shock/Stimulation 22640 22648
High impedance 20731 20749
Adverse Event Without Identified Device or Use Problem 18866 18882
Premature Discharge of Battery 18703 18711
Signal Artifact/Noise 18175 18185
Incorrect, Inadequate or Imprecise Result or Readings 8546 8548
Fracture 8184 8189
Impedance Problem 7648 7656
Device Sensing Problem 7378 7382
Failure to Read Input Signal 7339 7340
Pacing Problem 7115 7122
High Capture Threshold 6715 6721
Under-Sensing 6190 6197
Battery Problem 5175 5177
Low impedance 4233 4235
Premature Elective Replacement Indicator 2999 3003
Failure to Capture 2803 2810
Device Dislodged or Dislocated 2540 2543
Defective Device 2442 2448
Decreased Sensitivity 2310 2313
Capturing Problem 2008 2011
Noise, Audible 1829 1829
Appropriate Device Problem Term/Code Not Available 1794 1797
Failure to Convert Rhythm 1733 1735
Inappropriate or Unexpected Reset 1228 1228
Defibrillation/Stimulation Problem 1223 1223
Data Problem 1124 1125
Electromagnetic Interference 1082 1083
Break 1071 1072
Mechanical Problem 1031 1031
Insufficient Device Problem Information 917 918
Failure to Deliver Shock/Stimulation 878 878
Failure to Interrogate 833 833
Inaccurate Synchronization 826 826
Premature End-of-Life Indicator 810 810
Interrogation Problem 804 805
Connection Problem 780 781
Material Integrity Problem 759 760
Electrical /Electronic Property Problem 726 727
Migration 703 703
Use of Device Problem 655 655
Positioning Problem 645 645
Unstable Capture Threshold 568 568
Activation, Positioning or Separation Problem 500 500
Unexpected Therapeutic Results 478 478
No Apparent Adverse Event 476 481
Nonstandard Device 455 455
Incorrect Interpretation of Signal 411 412
Environmental Compatibility Problem 409 409

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 84806 84876
Shock from Patient Lead(s) 15338 15343
Unspecified Infection 14594 14600
Electric Shock 7092 7095
Insufficient Information 4026 4028
Sepsis 1591 1591
Discomfort 1448 1449
Syncope/Fainting 1292 1294
Arrhythmia 1288 1291
Ventricular Fibrillation 1247 1248
Pocket Erosion 1168 1170
Tachycardia 1162 1164
Pain 1079 1080
Bacterial Infection 1034 1034
No Code Available 946 946
Bradycardia 823 824
Bacteremia 806 806
Erythema 790 791
Erosion 790 791
Swelling/ Edema 787 788
Dizziness 762 764
Purulent Discharge 717 717
Chest Pain 684 685
Medical device site infection 612 612
Wound Dehiscence 611 611
Dyspnea 543 544
Fever 525 525
Cardiac Arrest 508 510
Hematoma 505 506
Endocarditis 498 500
No Known Impact Or Consequence To Patient 457 457
Twiddlers Syndrome 430 430
Asystole 427 427
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 424 425
Cardiac Perforation 384 385
Pericardial Effusion 316 316
Obstruction/Occlusion 287 288
Fall 282 282
Foreign Body In Patient 282 283
No Consequences Or Impact To Patient 264 264
Device Overstimulation of Tissue 262 262
Drug Resistant Bacterial Infection 261 261
Perforation 256 256
Fluid Discharge 245 245
Failure of Implant 235 238
Anxiety 216 217
Atrial Fibrillation 200 201
Low Blood Pressure/ Hypotension 192 192
Presyncope 191 191
Heart Failure/Congestive Heart Failure 187 188

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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