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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 10

MDR Year MDR Reports MDR Events
2020 16910 16910
2021 19657 19657
2022 23462 23462
2023 28724 28724
2024 25247 25248
2025 2153 2153

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 27859 27859
High impedance 17664 17664
Inappropriate/Inadequate Shock/Stimulation 17365 17365
Premature Discharge of Battery 17284 17284
Adverse Event Without Identified Device or Use Problem 17032 17032
Signal Artifact/Noise 14595 14595
Fracture 7686 7686
Incorrect, Inadequate or Imprecise Result or Readings 6799 6799
Impedance Problem 6394 6394
High Capture Threshold 6027 6027
Device Sensing Problem 5842 5842
Failure to Read Input Signal 5221 5221
Battery Problem 5084 5084
Pacing Problem 4883 4883
Under-Sensing 4721 4721
Low impedance 3540 3540
Device Dislodged or Dislocated 2555 2555
Failure to Capture 2448 2448
Premature Elective Replacement Indicator 2430 2431
Defective Device 2407 2407
Decreased Sensitivity 2205 2205
Capturing Problem 1760 1760
Noise, Audible 1565 1565
Failure to Convert Rhythm 1216 1216
Appropriate Term/Code Not Available 1201 1201
Break 1033 1033
Data Problem 983 983
Mechanical Problem 972 972
Inappropriate or Unexpected Reset 963 963
Electromagnetic Interference 904 904
Electrical /Electronic Property Problem 825 825
Failure to Interrogate 746 746
Connection Problem 743 743
Inaccurate Synchronization 727 727
Failure to Deliver Shock/Stimulation 690 690
Material Integrity Problem 678 678
Defibrillation/Stimulation Problem 671 671
Premature End-of-Life Indicator 609 609
Interrogation Problem 608 608
Positioning Problem 585 585
Insufficient Information 571 571
No Apparent Adverse Event 540 540
Migration 527 527
Unstable Capture Threshold 512 512
Activation, Positioning or Separation Problem 461 461
Unexpected Therapeutic Results 390 390
Positioning Failure 382 382
Use of Device Problem 364 364
Nonstandard Device 360 360
Incorrect Interpretation of Signal 340 340

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 63458 63459
Unspecified Infection 13789 13789
Shock from Patient Lead(s) 8708 8708
Electric Shock 7919 7919
No Known Impact Or Consequence To Patient 5189 5189
No Consequences Or Impact To Patient 4556 4556
Insufficient Information 3719 3719
No Code Available 3335 3335
Sepsis 1841 1841
Pocket Erosion 1112 1112
Discomfort 1028 1028
Arrhythmia 959 959
Syncope/Fainting 957 957
Ventricular Fibrillation 867 867
Pain 837 837
Bacterial Infection 749 749
Tachycardia 737 737
Bradycardia 695 695
Erosion 654 654
Dizziness 601 601
Chest Pain 534 534
Hematoma 482 482
Swelling/ Edema 478 478
Endocarditis 466 466
Dyspnea 444 444
Wound Dehiscence 424 424
Purulent Discharge 424 424
Cardiac Arrest 422 422
Erythema 410 410
Cardiac Perforation 389 389
Fever 367 367
Twiddlers Syndrome 347 347
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 329 329
Asystole 316 316
Pericardial Effusion 301 301
Foreign Body In Patient 266 266
Perforation 241 241
Fall 235 235
Obstruction/Occlusion 231 231
Device Overstimulation of Tissue 203 203
Fluid Discharge 190 190
Failure of Implant 174 174
Death 166 166
Low Blood Pressure/ Hypotension 158 158
Atrial Fibrillation 158 158
Syncope 154 154
Drug Resistant Bacterial Infection 147 147
No Patient Involvement 143 143
Anxiety 143 143
Cardiac Tamponade 138 138

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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