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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)
2021 2022 2023 2024 2025 2026
67 62 58 56 56 31

MDR Year MDR Reports MDR Events
2021 10134 10144
2022 10646 10662
2023 11897 11923
2024 11697 11712
2025 11012 11014
2026 5502 5505

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 17955 17971
Adverse Event Without Identified Device or Use Problem 9995 10012
Pacing Problem 4729 4733
Inappropriate/Inadequate Shock/Stimulation 4159 4165
Failure to Capture 3552 3555
High impedance 3532 3540
Premature Discharge of Battery 3413 3418
Failure to Interrogate 2512 2512
Device Sensing Problem 2340 2341
Signal Artifact/Noise 2188 2192
Device Dislodged or Dislocated 2014 2015
Inappropriate or Unexpected Reset 1743 1745
Under-Sensing 1512 1512
Capturing Problem 1147 1152
Incorrect Measurement 1135 1141
Incorrect Interpretation of Signal 940 940
Defective Device 831 832
Appropriate Device Problem Term/Code Not Available 800 802
High Capture Threshold 751 752
Failure to Deliver Shock/Stimulation 750 751
Electrical /Electronic Property Problem 711 712
Mechanical Problem 705 707
Incorrect, Inadequate or Imprecise Result or Readings 668 669
Pacing Asynchronously 658 659
Electromagnetic Interference 644 648
Environmental Compatibility Problem 636 637
Low impedance 634 636
Therapy Delivered to Incorrect Body Area 621 622
Loose or Intermittent Connection 581 581
Break 573 574
Battery Problem 524 524
Insufficient Device Problem Information 506 506
Failure to Advance 494 494
Interrogation Problem 467 467
Failure to Read Input Signal 465 465
Premature Elective Replacement Indicator 460 461
Failure to Convert Rhythm 440 441
Connection Problem 398 399
Data Problem 381 381
Defibrillation/Stimulation Problem 367 367
Inaccurate Synchronization 347 347
Impedance Problem 342 343
Use of Device Problem 334 334
No Apparent Adverse Event 298 301
Difficult to Remove 283 283
Fracture 278 279
Migration or Expulsion of Device 270 270
No Pacing 243 243
Unable to Obtain Readings 237 237
Separation Failure 232 232

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 41532 41585
Unspecified Infection 7907 7911
Shock from Patient Lead(s) 2149 2153
Insufficient Information 2085 2087
Discomfort 1525 1526
Arrhythmia 1364 1366
Pocket Erosion 955 955
Tachycardia 631 631
Sepsis 618 618
Syncope/Fainting 581 582
Bradycardia 533 535
Electric Shock 530 531
Ventricular Fibrillation 465 465
Hematoma 375 375
Bacterial Infection 371 371
Erosion 371 372
Wound Dehiscence 358 358
Dizziness 354 354
Dyspnea 337 337
Asystole 333 334
Erythema 333 334
Pain 327 327
Swelling/ Edema 284 284
Purulent Discharge 269 269
Bacteremia 249 249
Fever 234 234
Heart Failure/Congestive Heart Failure 202 203
No Consequences Or Impact To Patient 196 196
Medical device site infection 177 177
Endocarditis 175 175
Fatigue 165 165
Device Overstimulation of Tissue 161 161
Chest Pain 155 155
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 151 151
No Code Available 145 145
Cardiac Arrest 134 134
Atrial Fibrillation 101 102
Low Blood Pressure/ Hypotension 99 100
Fall 89 89
Fluid Discharge 82 82
Drug Resistant Bacterial Infection 81 81
No Known Impact Or Consequence To Patient 67 67
Muscle Weakness/Atrophy 63 63
Pericardial Effusion 60 60
Loss of consciousness 51 51
Twiddlers Syndrome 49 49
Hemorrhage/Blood Loss/Bleeding 49 49
Failure of Implant 49 49
Hypersensitivity/Allergic reaction 47 47
Septic Shock 47 47

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