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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 50

MDR Year MDR Reports MDR Events
2021 19655 19669
2022 23453 23483
2023 28700 28734
2024 25199 25219
2025 24631 24631
2026 7788 7788

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 32365 32388
Inappropriate/Inadequate Shock/Stimulation 21086 21096
High impedance 19638 19656
Premature Discharge of Battery 18367 18373
Adverse Event Without Identified Device or Use Problem 17870 17886
Signal Artifact/Noise 16943 16952
Incorrect, Inadequate or Imprecise Result or Readings 8322 8322
Fracture 7742 7746
Impedance Problem 7225 7233
Device Sensing Problem 6860 6865
Failure to Read Input Signal 6681 6682
Pacing Problem 6518 6526
High Capture Threshold 6328 6333
Under-Sensing 5749 5756
Battery Problem 5104 5106
Low impedance 4001 4003
Premature Elective Replacement Indicator 2885 2888
Failure to Capture 2644 2651
Defective Device 2476 2482
Device Dislodged or Dislocated 2439 2442
Decreased Sensitivity 2234 2237
Capturing Problem 1900 1902
Noise, Audible 1790 1790
Appropriate Term/Code Not Available 1623 1626
Failure to Convert Rhythm 1577 1579
Inappropriate or Unexpected Reset 1155 1155
Defibrillation/Stimulation Problem 1068 1069
Data Problem 1044 1045
Break 1033 1035
Mechanical Problem 987 987
Electromagnetic Interference 971 972
Failure to Deliver Shock/Stimulation 835 835
Inaccurate Synchronization 826 826
Failure to Interrogate 798 798
Insufficient Information 797 798
Premature End-of-Life Indicator 760 760
Connection Problem 750 751
Interrogation Problem 735 736
Electrical /Electronic Property Problem 718 719
Material Integrity Problem 706 707
Migration 659 659
Positioning Problem 609 609
Use of Device Problem 531 532
Unstable Capture Threshold 525 525
No Apparent Adverse Event 472 477
Activation, Positioning or Separation Problem 465 465
Unexpected Therapeutic Results 444 444
Nonstandard Device 429 429
Incorrect Interpretation of Signal 399 400
Environmental Compatibility Problem 383 383

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 80225 80292
Unspecified Infection 13878 13884
Shock from Patient Lead(s) 13690 13695
Electric Shock 7081 7084
Insufficient Information 3988 3990
Sepsis 1536 1536
Discomfort 1354 1355
Arrhythmia 1243 1246
Syncope/Fainting 1193 1195
Pocket Erosion 1127 1129
Ventricular Fibrillation 1124 1125
Tachycardia 1040 1042
Pain 1010 1011
Bacterial Infection 980 980
No Code Available 946 946
Bradycardia 773 774
Swelling/ Edema 710 711
Erythema 705 706
Erosion 698 699
Dizziness 688 690
Chest Pain 636 637
Purulent Discharge 633 633
Wound Dehiscence 546 546
Dyspnea 513 514
Fever 485 485
Endocarditis 476 478
Hematoma 469 470
Cardiac Arrest 468 470
No Known Impact Or Consequence To Patient 457 457
Twiddlers Syndrome 421 421
Asystole 406 406
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 400 401
Cardiac Perforation 372 373
Pericardial Effusion 298 298
Foreign Body In Patient 280 281
Obstruction/Occlusion 277 278
No Consequences Or Impact To Patient 264 264
Fall 253 253
Device Overstimulation of Tissue 244 244
Fluid Discharge 237 237
Perforation 237 237
Drug Resistant Bacterial Infection 234 234
Failure of Implant 231 234
Anxiety 193 194
Atrial Fibrillation 186 187
Low Blood Pressure/ Hypotension 185 185
Heart Failure/Congestive Heart Failure 176 177
Hypersensitivity/Allergic reaction 172 172
Presyncope 166 166
Impaired Healing 140 140

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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