Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 10

MDR Year MDR Reports MDR Events
2021 10134 10144
2022 10646 10662
2023 11897 11923
2024 11698 11713
2025 11013 11015
2026 1800 1801

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 16792 16808
Adverse Event Without Identified Device or Use Problem 9450 9467
Pacing Problem 4402 4406
Inappropriate/Inadequate Shock/Stimulation 3872 3877
High impedance 3312 3320
Failure to Capture 3301 3304
Premature Discharge of Battery 3280 3285
Failure to Interrogate 2384 2384
Device Sensing Problem 2173 2174
Signal Artifact/Noise 2035 2039
Device Dislodged or Dislocated 1924 1925
Inappropriate or Unexpected Reset 1629 1631
Under-Sensing 1411 1411
Incorrect Measurement 1115 1121
Capturing Problem 1087 1092
Incorrect Interpretation of Signal 861 861
Defective Device 835 836
Appropriate Term/Code Not Available 761 763
Failure to Deliver Shock/Stimulation 709 710
High Capture Threshold 706 707
Electrical /Electronic Property Problem 700 701
Mechanical Problem 664 666
Incorrect, Inadequate or Imprecise Result or Readings 628 629
Pacing Asynchronously 617 618
Electromagnetic Interference 612 615
Therapy Delivered to Incorrect Body Area 592 593
Low impedance 590 592
Environmental Compatibility Problem 583 584
Loose or Intermittent Connection 537 537
Break 534 535
Battery Problem 492 492
Failure to Advance 467 467
Insufficient Information 461 461
Premature Elective Replacement Indicator 433 434
Interrogation Problem 429 429
Failure to Read Input Signal 417 417
Failure to Convert Rhythm 408 409
Connection Problem 363 364
Data Problem 352 352
Inaccurate Synchronization 348 348
Impedance Problem 330 331
Use of Device Problem 313 313
Defibrillation/Stimulation Problem 299 299
Difficult to Remove 279 279
No Apparent Adverse Event 269 272
Fracture 267 268
Migration or Expulsion of Device 263 263
No Pacing 235 235
Unable to Obtain Readings 231 231
Separation Failure 212 212

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 38939 38991
Unspecified Infection 7485 7489
Shock from Patient Lead(s) 1979 1983
Insufficient Information 1966 1967
Discomfort 1425 1426
Arrhythmia 1277 1279
Pocket Erosion 896 896
Sepsis 597 597
Tachycardia 577 577
Syncope/Fainting 538 539
Electric Shock 530 531
Bradycardia 509 511
Ventricular Fibrillation 424 424
Hematoma 354 354
Bacterial Infection 348 348
Erosion 345 346
Dizziness 329 329
Wound Dehiscence 328 328
Erythema 313 314
Dyspnea 312 312
Asystole 307 308
Pain 303 303
Swelling/ Edema 257 257
Purulent Discharge 237 237
Fever 211 211
No Consequences Or Impact To Patient 196 196
Heart Failure/Congestive Heart Failure 183 184
Endocarditis 164 164
Fatigue 151 151
Chest Pain 148 148
Device Overstimulation of Tissue 147 147
No Code Available 145 145
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 141 141
Cardiac Arrest 123 123
Atrial Fibrillation 94 95
Low Blood Pressure/ Hypotension 92 93
Fall 81 81
Fluid Discharge 78 78
Drug Resistant Bacterial Infection 76 76
No Known Impact Or Consequence To Patient 67 67
Muscle Weakness 60 60
Pericardial Effusion 54 54
Failure of Implant 47 47
Hemorrhage/Bleeding 47 47
Septic Shock 44 44
Impaired Healing 43 43
Twiddlers Syndrome 43 43
Loss of consciousness 42 42
Non specific EKG/ECG Changes 40 40
Hypersensitivity/Allergic reaction 40 40

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
-
-