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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 33

MDR Year MDR Reports MDR Events
2019 7265 7265
2020 9609 9609
2021 10134 10134
2022 10646 10646
2023 11899 11899
2024 7938 7938

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 15922 15922
Adverse Event Without Identified Device or Use Problem 10342 10342
Premature Discharge of Battery 4133 4133
Inappropriate/Inadequate Shock/Stimulation 3271 3271
Pacing Problem 3199 3199
High impedance 3189 3189
Failure to Capture 3081 3081
Device Dislodged or Dislocated 2206 2206
Device Sensing Problem 2007 2007
Inappropriate or Unexpected Reset 1874 1874
Signal Artifact/Noise 1844 1844
Failure to Interrogate 1838 1838
Battery Problem 1272 1272
Under-Sensing 1141 1141
Electrical /Electronic Property Problem 1121 1121
Incorrect Measurement 1117 1117
High Capture Threshold 907 907
Capturing Problem 845 845
Defective Device 782 782
Incorrect Interpretation of Signal 704 704
Mechanical Problem 692 692
Electromagnetic Interference 678 678
Appropriate Term/Code Not Available 664 664
Failure to Deliver Shock/Stimulation 652 652
Low impedance 503 503
Break 489 489
Therapy Delivered to Incorrect Body Area 466 466
Pacing Asynchronously 448 448
Incorrect, Inadequate or Imprecise Result or Readings 447 447
Data Problem 427 427
Environmental Compatibility Problem 399 399
Loose or Intermittent Connection 387 387
Failure to Advance 383 383
Premature Elective Replacement Indicator 377 377
Insufficient Information 351 351
Reset Problem 336 336
Failure to Convert Rhythm 335 335
Impedance Problem 313 313
Connection Problem 303 303
Difficult to Remove 299 299
Inaccurate Synchronization 267 267
Communication or Transmission Problem 265 265
No Pacing 258 258
Unable to Obtain Readings 258 258
Interrogation Problem 257 257
Fracture 254 254
Use of Device Problem 250 250
Failure to Read Input Signal 245 245
Migration or Expulsion of Device 244 244
Misconnection 219 219

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28492 28492
No Known Impact Or Consequence To Patient 8277 8278
Unspecified Infection 8097 8097
No Consequences Or Impact To Patient 2531 2532
Shock from Patient Lead(s) 1504 1504
Insufficient Information 1474 1474
Discomfort 1096 1096
Arrhythmia 1003 1003
Pocket Erosion 932 932
Sepsis 896 896
No Code Available 656 656
Electric Shock 596 596
No Patient Involvement 467 467
Bradycardia 418 418
Hematoma 416 416
Tachycardia 416 416
Death 408 408
Syncope/Fainting 379 379
Ventricular Fibrillation 359 359
Dyspnea 330 330
Erosion 323 323
Dizziness 311 311
Therapeutic Effects, Unexpected 300 300
Pain 274 274
Bacterial Infection 267 267
Wound Dehiscence 264 264
Endocarditis 204 204
Asystole 195 195
Erythema 181 181
Fever 179 179
Fatigue 161 161
Swelling/ Edema 150 150
Purulent Discharge 148 148
Cardiac Arrest 135 135
Muscle Stimulation 128 128
Undesired Nerve Stimulation 127 127
Ventricular Tachycardia 126 126
Heart Failure/Congestive Heart Failure 125 125
Chest Pain 124 124
No Information 122 122
Device Overstimulation of Tissue 112 112
Syncope 112 112
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 107 107
Atrial Fibrillation 94 94
Twiddlers Syndrome 80 80
Fall 80 80
Low Blood Pressure/ Hypotension 79 79
Fluid Discharge 68 68
Pericardial Effusion 54 54
Swelling 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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