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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 49

MDR Year MDR Reports MDR Events
2020 9609 9611
2021 10134 10135
2022 10646 10647
2023 11897 11897
2024 11698 11698
2025 9216 9218

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 18196 18197
Adverse Event Without Identified Device or Use Problem 10800 10800
Pacing Problem 4280 4281
Inappropriate/Inadequate Shock/Stimulation 4050 4050
Premature Discharge of Battery 3952 3953
High impedance 3603 3603
Failure to Capture 3590 3590
Failure to Interrogate 2379 2379
Device Sensing Problem 2306 2306
Device Dislodged or Dislocated 2300 2300
Signal Artifact/Noise 2192 2192
Inappropriate or Unexpected Reset 1918 1918
Under-Sensing 1423 1423
Incorrect Measurement 1159 1159
Capturing Problem 1081 1081
Electrical /Electronic Property Problem 995 995
High Capture Threshold 913 913
Incorrect Interpretation of Signal 896 896
Defective Device 886 886
Battery Problem 834 834
Appropriate Term/Code Not Available 793 793
Failure to Deliver Shock/Stimulation 762 762
Mechanical Problem 727 727
Electromagnetic Interference 723 723
Incorrect, Inadequate or Imprecise Result or Readings 644 644
Low impedance 603 603
Therapy Delivered to Incorrect Body Area 597 597
Break 588 588
Pacing Asynchronously 586 586
Environmental Compatibility Problem 533 533
Loose or Intermittent Connection 532 532
Failure to Advance 492 492
Premature Elective Replacement Indicator 447 447
Data Problem 428 428
Insufficient Information 426 426
Interrogation Problem 412 412
Failure to Convert Rhythm 407 407
Inaccurate Synchronization 374 374
Connection Problem 373 373
Failure to Read Input Signal 372 372
Reset Problem 352 352
Impedance Problem 342 342
Difficult to Remove 317 317
Use of Device Problem 299 299
Fracture 289 289
Migration or Expulsion of Device 275 275
No Pacing 272 272
Unable to Obtain Readings 257 257
No Apparent Adverse Event 255 255
Separation Failure 253 253

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 37228 37230
Unspecified Infection 8526 8526
No Known Impact Or Consequence To Patient 3800 3802
No Consequences Or Impact To Patient 2373 2374
Shock from Patient Lead(s) 2021 2021
Insufficient Information 1868 1868
Discomfort 1417 1417
Arrhythmia 1269 1269
Pocket Erosion 1046 1046
Sepsis 792 792
No Code Available 608 608
Electric Shock 594 594
Tachycardia 547 547
Bradycardia 529 530
Syncope/Fainting 515 515
Ventricular Fibrillation 426 426
Hematoma 408 408
Erosion 387 387
Dyspnea 354 354
Dizziness 350 350
Bacterial Infection 345 345
Wound Dehiscence 334 334
Pain 330 330
Erythema 293 293
Asystole 287 288
No Patient Involvement 262 262
Swelling/ Edema 235 235
Fever 224 224
Purulent Discharge 224 224
Death 215 215
Endocarditis 199 199
Fatigue 175 175
Therapeutic Effects, Unexpected 175 175
Heart Failure/Congestive Heart Failure 161 161
Chest Pain 158 158
Device Overstimulation of Tissue 139 139
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 137 137
Cardiac Arrest 135 135
Low Blood Pressure/ Hypotension 100 100
Atrial Fibrillation 98 99
Undesired Nerve Stimulation 97 97
Fall 86 86
Muscle Stimulation 80 80
Fluid Discharge 79 79
Ventricular Tachycardia 77 77
Drug Resistant Bacterial Infection 69 69
Pericardial Effusion 63 63
No Information 62 62
Muscle Weakness 58 58
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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