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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 1

MDR Year MDR Reports MDR Events
2020 9609 9609
2021 10134 10134
2022 10646 10646
2023 11899 11899
2024 11704 11704

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 15423 15423
Adverse Event Without Identified Device or Use Problem 9225 9225
Premature Discharge of Battery 3629 3629
Pacing Problem 3378 3378
Inappropriate/Inadequate Shock/Stimulation 3303 3303
Failure to Capture 3014 3014
High impedance 2941 2941
Device Dislodged or Dislocated 2050 2050
Failure to Interrogate 1941 1941
Device Sensing Problem 1871 1871
Signal Artifact/Noise 1810 1810
Inappropriate or Unexpected Reset 1692 1692
Under-Sensing 1170 1170
Incorrect Measurement 1116 1116
Electrical /Electronic Property Problem 946 946
Capturing Problem 900 900
High Capture Threshold 789 789
Defective Device 773 773
Battery Problem 760 760
Incorrect Interpretation of Signal 740 740
Failure to Deliver Shock/Stimulation 652 652
Appropriate Term/Code Not Available 637 637
Mechanical Problem 631 631
Electromagnetic Interference 618 618
Break 495 495
Therapy Delivered to Incorrect Body Area 493 493
Low impedance 492 492
Pacing Asynchronously 485 485
Incorrect, Inadequate or Imprecise Result or Readings 474 474
Environmental Compatibility Problem 442 442
Loose or Intermittent Connection 406 406
Failure to Advance 402 402
Data Problem 378 378
Premature Elective Replacement Indicator 376 376
Insufficient Information 355 355
Failure to Convert Rhythm 338 338
Reset Problem 335 335
Interrogation Problem 307 307
Impedance Problem 303 303
Inaccurate Synchronization 295 295
Difficult to Remove 294 294
Connection Problem 292 292
Failure to Read Input Signal 269 269
Use of Device Problem 256 256
Fracture 251 251
Unable to Obtain Readings 242 242
Migration or Expulsion of Device 228 228
No Pacing 226 226
No Apparent Adverse Event 217 217
Defibrillation/Stimulation Problem 217 217

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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