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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Definition These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.
Product CodeNIK
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
75 67 62 58 56 15

MDR Year MDR Reports MDR Events
2020 9609 9609
2021 10134 10134
2022 10646 10646
2023 11899 11899
2024 11705 11705
2025 2788 2788

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 16244 16244
Adverse Event Without Identified Device or Use Problem 9683 9683
Premature Discharge of Battery 3723 3723
Pacing Problem 3641 3641
Inappropriate/Inadequate Shock/Stimulation 3524 3524
Failure to Capture 3182 3182
High impedance 3119 3119
Failure to Interrogate 2132 2132
Device Dislodged or Dislocated 2120 2120
Device Sensing Problem 2004 2004
Signal Artifact/Noise 1927 1927
Inappropriate or Unexpected Reset 1749 1749
Under-Sensing 1250 1250
Incorrect Measurement 1135 1135
Electrical /Electronic Property Problem 979 979
Capturing Problem 965 965
High Capture Threshold 820 820
Defective Device 809 809
Incorrect Interpretation of Signal 787 787
Battery Problem 782 782
Failure to Deliver Shock/Stimulation 684 684
Appropriate Term/Code Not Available 680 680
Mechanical Problem 669 669
Electromagnetic Interference 644 644
Therapy Delivered to Incorrect Body Area 527 527
Low impedance 524 524
Break 523 523
Pacing Asynchronously 517 517
Incorrect, Inadequate or Imprecise Result or Readings 508 508
Environmental Compatibility Problem 459 459
Loose or Intermittent Connection 436 436
Failure to Advance 421 421
Data Problem 396 396
Premature Elective Replacement Indicator 394 394
Insufficient Information 375 375
Failure to Convert Rhythm 356 356
Interrogation Problem 344 344
Reset Problem 342 342
Inaccurate Synchronization 316 316
Impedance Problem 316 316
Connection Problem 307 307
Difficult to Remove 299 299
Failure to Read Input Signal 297 297
Fracture 266 266
Use of Device Problem 265 265
Unable to Obtain Readings 248 248
Migration or Expulsion of Device 241 241
No Pacing 240 240
No Apparent Adverse Event 233 233
Defibrillation/Stimulation Problem 228 228

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 32933 32933
Unspecified Infection 7706 7706
No Known Impact Or Consequence To Patient 3800 3800
No Consequences Or Impact To Patient 2373 2374
Shock from Patient Lead(s) 1681 1681
Insufficient Information 1653 1653
Discomfort 1240 1240
Arrhythmia 1127 1127
Pocket Erosion 929 929
Sepsis 754 754
No Code Available 608 608
Electric Shock 590 590
Tachycardia 485 485
Bradycardia 465 465
Syncope/Fainting 446 446
Hematoma 375 375
Ventricular Fibrillation 374 374
Erosion 327 327
Dyspnea 315 315
Dizziness 314 314
Bacterial Infection 290 290
Wound Dehiscence 281 281
Pain 279 279
No Patient Involvement 262 262
Asystole 238 238
Erythema 233 233
Death 215 215
Fever 190 190
Swelling/ Edema 187 187
Purulent Discharge 182 182
Therapeutic Effects, Unexpected 175 175
Endocarditis 175 175
Fatigue 156 156
Heart Failure/Congestive Heart Failure 135 135
Chest Pain 133 133
Device Overstimulation of Tissue 119 119
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 119 119
Cardiac Arrest 117 117
Undesired Nerve Stimulation 92 92
Atrial Fibrillation 85 85
Low Blood Pressure/ Hypotension 84 84
Muscle Stimulation 80 80
Fall 79 79
Ventricular Tachycardia 77 77
Fluid Discharge 67 67
No Information 62 62
Pericardial Effusion 57 57
Muscle Weakness 54 54
Drug Resistant Bacterial Infection 52 52
Syncope 52 52

Recalls
Manufacturer Recall Class Date Posted
1 Abbott II Apr-10-2020
2 Abbott Medical II Sep-19-2023
3 Boston Scientific Corporation II Sep-02-2022
4 Medtronic Inc. II Jun-26-2024
5 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Jun-16-2023
6 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Aug-09-2022
7 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jul-28-2022
8 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jun-14-2022
9 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II May-20-2021
10 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II May-04-2021
11 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Mar-27-2021
12 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jan-26-2021
13 St. Jude Medical, Cardiac Rhythm Management Division II Apr-21-2022
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