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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)
2019 2020 2021 2022 2023 2024
62 75 67 62 58 48

MDR Year MDR Reports MDR Events
2019 7265 7265
2020 9609 9609
2021 10134 10134
2022 10646 10646
2023 11899 11899
2024 10697 10697

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 16804 16804
Adverse Event Without Identified Device or Use Problem 10789 10789
Premature Discharge of Battery 4256 4256
Inappropriate/Inadequate Shock/Stimulation 3528 3528
Pacing Problem 3475 3475
High impedance 3318 3318
Failure to Capture 3227 3227
Device Dislodged or Dislocated 2276 2276
Device Sensing Problem 2132 2132
Failure to Interrogate 1997 1997
Signal Artifact/Noise 1964 1964
Inappropriate or Unexpected Reset 1937 1937
Battery Problem 1293 1293
Under-Sensing 1223 1223
Electrical /Electronic Property Problem 1132 1132
Incorrect Measurement 1128 1128
High Capture Threshold 947 947
Capturing Problem 898 898
Defective Device 821 821
Incorrect Interpretation of Signal 771 771
Mechanical Problem 737 737
Electromagnetic Interference 710 710
Appropriate Term/Code Not Available 707 707
Failure to Deliver Shock/Stimulation 695 695
Low impedance 533 533
Break 509 509
Therapy Delivered to Incorrect Body Area 488 488
Pacing Asynchronously 475 475
Incorrect, Inadequate or Imprecise Result or Readings 469 469
Data Problem 437 437
Environmental Compatibility Problem 426 426
Failure to Advance 410 410
Loose or Intermittent Connection 409 409
Premature Elective Replacement Indicator 396 396
Insufficient Information 366 366
Failure to Convert Rhythm 356 356
Reset Problem 341 341
Impedance Problem 337 337
Connection Problem 314 314
Difficult to Remove 307 307
Inaccurate Synchronization 286 286
Interrogation Problem 286 286
Communication or Transmission Problem 272 272
No Pacing 267 267
Use of Device Problem 266 266
Unable to Obtain Readings 266 266
Failure to Read Input Signal 263 263
Fracture 259 259
Migration or Expulsion of Device 249 249
Defibrillation/Stimulation Problem 234 234

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30373 30373
Unspecified Infection 8473 8473
No Known Impact Or Consequence To Patient 8277 8278
No Consequences Or Impact To Patient 2531 2532
Shock from Patient Lead(s) 1657 1657
Insufficient Information 1547 1547
Discomfort 1162 1162
Arrhythmia 1076 1076
Pocket Erosion 982 982
Sepsis 918 918
No Code Available 656 656
Electric Shock 599 599
No Patient Involvement 467 467
Bradycardia 453 453
Tachycardia 450 450
Hematoma 430 430
Syncope/Fainting 408 408
Death 408 408
Ventricular Fibrillation 381 381
Dyspnea 344 344
Erosion 339 339
Dizziness 328 328
Therapeutic Effects, Unexpected 300 300
Pain 294 294
Bacterial Infection 281 281
Wound Dehiscence 277 277
Asystole 215 215
Endocarditis 214 214
Erythema 205 205
Fever 196 196
Purulent Discharge 170 170
Fatigue 168 168
Swelling/ Edema 165 165
Cardiac Arrest 141 141
Chest Pain 137 137
Heart Failure/Congestive Heart Failure 131 131
Muscle Stimulation 128 128
Undesired Nerve Stimulation 127 127
Ventricular Tachycardia 126 126
No Information 122 122
Device Overstimulation of Tissue 117 117
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 113 113
Syncope 112 112
Atrial Fibrillation 101 101
Low Blood Pressure/ Hypotension 85 85
Fall 83 83
Twiddlers Syndrome 80 80
Fluid Discharge 72 72
Pericardial Effusion 57 57
Vascular Dissection 55 55

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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