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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 27

MDR Year MDR Reports MDR Events
2019 7265 7265
2020 9609 9609
2021 10134 10134
2022 10646 10646
2023 11899 11899
2024 5974 5974

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 15299 15299
Adverse Event Without Identified Device or Use Problem 10012 10012
Premature Discharge of Battery 4055 4055
Inappropriate/Inadequate Shock/Stimulation 3110 3110
High impedance 3085 3085
Pacing Problem 2989 2989
Failure to Capture 2982 2982
Device Dislodged or Dislocated 2160 2160
Device Sensing Problem 1919 1919
Inappropriate or Unexpected Reset 1803 1803
Signal Artifact/Noise 1762 1762
Failure to Interrogate 1716 1716
Battery Problem 1263 1263
Electrical /Electronic Property Problem 1108 1108
Incorrect Measurement 1102 1102
Under-Sensing 1076 1076
High Capture Threshold 881 881
Capturing Problem 814 814
Defective Device 767 767
Incorrect Interpretation of Signal 675 675
Mechanical Problem 667 667
Electromagnetic Interference 654 654
Failure to Deliver Shock/Stimulation 625 625
Appropriate Term/Code Not Available 622 622
Low impedance 489 489
Break 473 473
Therapy Delivered to Incorrect Body Area 451 451
Incorrect, Inadequate or Imprecise Result or Readings 430 430
Pacing Asynchronously 424 424
Data Problem 414 414
Loose or Intermittent Connection 368 368
Failure to Advance 368 368
Premature Elective Replacement Indicator 367 367
Environmental Compatibility Problem 359 359
Insufficient Information 339 339
Reset Problem 335 335
Failure to Convert Rhythm 323 323
Impedance Problem 301 301
Difficult to Remove 296 296
Connection Problem 291 291
Communication or Transmission Problem 260 260
Unable to Obtain Readings 257 257
No Pacing 253 253
Inaccurate Synchronization 251 251
Interrogation Problem 247 247
Use of Device Problem 242 242
Fracture 242 242
Migration or Expulsion of Device 232 232
Failure to Read Input Signal 230 230
Misconnection 216 216
Defibrillation/Stimulation Problem 211 211
No Apparent Adverse Event 192 192
Separation Failure 186 186
Failure to Charge 167 167
Wireless Communication Problem 165 165
Failure to Sense 163 163
Difficult to Insert 149 149
Missing Test Results 149 149
Premature End-of-Life Indicator 134 134
Failure to Disconnect 133 133
Migration 131 131
Unexpected Therapeutic Results 129 129
Output Problem 123 123
Intermittent Capture 118 118
Noise, Audible 116 116
Material Integrity Problem 114 114
Off-Label Use 104 104
Detachment of Device or Device Component 92 92
Delayed Charge Time 91 91
Pacemaker Found in Back-Up Mode 90 90
Compatibility Problem 80 80
Nonstandard Device 74 74
Product Quality Problem 67 67
Device Displays Incorrect Message 63 63
Protective Measures Problem 63 63
Pocket Stimulation 60 60
Contamination of Device Ingredient or Reagent 58 58
Program or Algorithm Execution Failure 49 49
Telemetry Discrepancy 47 47
Material Twisted/Bent 41 41
Therapeutic or Diagnostic Output Failure 40 40
Device Alarm System 38 38
Patient-Device Incompatibility 34 34
Unintended Electrical Shock 29 29
Fitting Problem 28 28
Component Missing 25 25
Display or Visual Feedback Problem 25 25
Charging Problem 24 24
Tactile Prompts/Feedback 21 21
Difficult to Advance 20 20
Pacing Intermittently 20 20
Sensing Intermittently 19 19
Failure to Select Signal 17 17
Device Contamination with Body Fluid 17 17
Use of Incorrect Control/Treatment Settings 16 16
Defective Alarm 16 16
Application Program Freezes, Becomes Nonfunctional 16 16
Positioning Problem 16 16
Defective Component 15 15
Smoking 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 27173 27173
No Known Impact Or Consequence To Patient 8277 8278
Unspecified Infection 7823 7823
No Consequences Or Impact To Patient 2531 2532
Insufficient Information 1420 1420
Shock from Patient Lead(s) 1393 1393
Discomfort 1058 1058
Arrhythmia 961 961
Pocket Erosion 899 899
Sepsis 884 884
No Code Available 656 656
Electric Shock 594 594
No Patient Involvement 467 467
Death 408 408
Hematoma 407 407
Tachycardia 398 398
Bradycardia 392 392
Syncope/Fainting 357 357
Ventricular Fibrillation 344 344
Dyspnea 317 317
Dizziness 303 303
Erosion 302 302
Therapeutic Effects, Unexpected 300 300
Pain 262 262
Bacterial Infection 257 257
Wound Dehiscence 246 246
Endocarditis 198 198
Asystole 173 173
Fever 172 172
Erythema 157 157
Fatigue 155 155
Swelling/ Edema 134 134
Cardiac Arrest 129 129
Muscle Stimulation 128 128
Purulent Discharge 127 127
Undesired Nerve Stimulation 127 127
Ventricular Tachycardia 126 126
No Information 122 122
Heart Failure/Congestive Heart Failure 120 120
Chest Pain 118 118
Syncope 112 112
Device Overstimulation of Tissue 103 103
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 103 103
Atrial Fibrillation 91 91
Twiddlers Syndrome 80 80
Fall 79 79
Low Blood Pressure/ Hypotension 77 77
Fluid Discharge 65 65
Pericardial Effusion 54 54
Swelling 52 52
Vascular Dissection 48 48
Muscle Weakness 47 47
Complaint, Ill-Defined 44 44
Impaired Healing 42 42
Drug Resistant Bacterial Infection 39 39
Non specific EKG/ECG Changes 38 38
Inflammation 37 37
Septic Shock 36 36
Hypersensitivity/Allergic reaction 34 34
Hemorrhage/Bleeding 31 31
Nausea 31 31
Pneumothorax 31 31
Staphylococcus Aureus 30 30
Cardiac Perforation 30 30
Twiddlers Syndrome 28 28
Thrombosis/Thrombus 27 27
Loss of consciousness 27 27
Presyncope 27 27
Pleural Effusion 27 27
Failure of Implant 27 27
Stroke/CVA 26 26
Palpitations 26 26
Vomiting 23 23
Heart Failure 23 23
Cardiac Tamponade 21 21
Weakness 21 21
Abscess 21 21
Anxiety 21 21
Cardiogenic Shock 21 21
Chills 20 20
Heart Block 17 17
Discharge 16 16
Bruise/Contusion 14 14
Implant Pain 14 14
Respiratory Failure 13 13
Complete Heart Block 13 13
High Blood Pressure/ Hypertension 13 13
Congestive Heart Failure 12 12
Necrosis 12 12
Foreign Body In Patient 12 12
Unspecified Heart Problem 12 12
Pulmonary Edema 11 11
Cardiopulmonary Arrest 11 11
Cellulitis 11 11
Cardiomyopathy 10 10
Pneumonia 10 10
Myocardial Infarction 10 10
Itching Sensation 10 10
Malaise 10 10
Skin Inflammation/ Irritation 9 9

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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