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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
43 51 50 83 50 76 49 109 112 91 62 75 67 62 58 10

MDR Year MDR Reports MDR Events
2014 10733 10733
2015 7828 7828
2016 13254 13254
2017 16262 16262
2018 8347 8347
2019 7265 7265
2020 9609 9609
2021 10134 10134
2022 10646 10646
2023 11898 11898
2024 2936 2936

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 29085 29085
Over-Sensing 26222 26222
Premature Discharge of Battery 11842 11842
High impedance 5504 5504
Inappropriate/Inadequate Shock/Stimulation 5192 5192
Failure to Capture 4139 4139
Pacing Problem 3832 3832
Inappropriate or Unexpected Reset 3155 3155
Device Dislodged or Dislocated 2847 2847
Battery Problem 2579 2579
Failure to Interrogate 2352 2352
Device Sensing Problem 2316 2316
Signal Artifact/Noise 1913 1913
Electrical /Electronic Property Problem 1682 1682
Under-Sensing 1607 1607
Device Operates Differently Than Expected 1517 1517
Mechanical Problem 1469 1469
Capturing Problem 1194 1194
Appropriate Term/Code Not Available 1191 1191
Incorrect Measurement 1185 1185
High Capture Threshold 1179 1179
Invalid Sensing 881 881
Low impedance 877 877
Connection Problem 833 833
Electromagnetic Interference 772 772
Defective Device 766 766
Nonstandard Device 732 732
Incorrect Interpretation of Signal 695 695
Device Displays Incorrect Message 667 667
Premature Elective Replacement Indicator 665 665
Fracture 612 612
Failure to Deliver Shock/Stimulation 608 608
Defibrillation/Stimulation Problem 582 582
Break 530 530
Impedance Problem 512 512
Data Problem 498 498
Insufficient Information 491 491
Communication or Transmission Problem 490 490
Misconnection 467 467
Ambient Noise Problem 466 466
Failure to Convert Rhythm 464 464
Loose or Intermittent Connection 447 447
Reset Problem 422 422
Therapy Delivered to Incorrect Body Area 412 412
Incorrect, Inadequate or Imprecise Result or Readings 411 411
Migration or Expulsion of Device 404 404
Pacing Asynchronously 394 394
Difficult to Remove 385 385
Delayed Charge Time 382 382
Unable to Obtain Readings 380 380
Failure to Advance 350 350
Output Problem 331 331
Environmental Compatibility Problem 318 318
Use of Device Problem 311 311
No Pacing 297 297
Material Integrity Problem 296 296
Premature End-of-Life Indicator 263 263
Device Alarm System 244 244
Inaccurate Synchronization 233 233
Interrogation Problem 233 233
Failure to Sense 227 227
Difficult to Insert 218 218
Failure to Charge 216 216
Failure to Read Input Signal 203 203
Pocket Stimulation 203 203
No Apparent Adverse Event 203 203
Protective Measures Problem 199 199
False Alarm 198 198
Pacemaker Found in Back-Up Mode 194 194
Intermittent Capture 188 188
Separation Failure 184 184
Missing Test Results 167 167
Wireless Communication Problem 165 165
Failure to Disconnect 136 136
Migration 134 134
Noise, Audible 134 134
Unexpected Therapeutic Results 128 128
Difficult to Interrogate 104 104
Telemetry Discrepancy 100 100
Off-Label Use 100 100
Fitting Problem 93 93
Detachment of Device or Device Component 89 89
Decreased Sensitivity 86 86
Therapeutic or Diagnostic Output Failure 83 83
Compatibility Problem 78 78
Product Quality Problem 64 64
Contamination of Device Ingredient or Reagent 57 57
Pacing Inadequately 53 53
Programming Issue 52 52
Program or Algorithm Execution Failure 49 49
Component Missing 45 45
Material Twisted/Bent 41 41
Defective Alarm 40 40
Charging Problem 39 39
No Device Output 38 38
Sensing Intermittently 37 37
Patient-Device Incompatibility 37 37
Vibration 36 36
Display or Visual Feedback Problem 33 33
Device Contamination with Body Fluid 31 31

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 50508 50511
No Clinical Signs, Symptoms or Conditions 25109 25109
Unspecified Infection 10655 10655
No Consequences Or Impact To Patient 5151 5152
Shock from Patient Lead(s) 3086 3086
Death 1961 1961
Insufficient Information 1354 1354
Sepsis 1353 1353
Pocket Erosion 1139 1139
Discomfort 1112 1112
No Code Available 1053 1053
Arrhythmia 972 972
No Patient Involvement 896 896
Hematoma 868 868
Ventricular Fibrillation 638 638
Electric Shock 612 612
Dyspnea 575 575
Syncope 571 571
Therapeutic Effects, Unexpected 534 534
Dizziness 513 513
Ventricular Tachycardia 496 496
Erosion 473 473
Bradycardia 472 472
Device Overstimulation of Tissue 470 470
Pain 462 462
Muscle Stimulation 391 391
Tachycardia 383 383
No Information 375 375
Endocarditis 374 374
Cardiac Arrest 349 349
Complaint, Ill-Defined 330 330
Syncope/Fainting 328 328
Fatigue 319 319
Wound Dehiscence 290 290
Bacterial Infection 284 284
Chest Pain 238 238
Fever 230 230
Atrial Fibrillation 218 218
Undesired Nerve Stimulation 192 192
Fall 170 170
Twiddlers Syndrome 170 170
Heart Failure 162 162
Asystole 156 156
Swelling 153 153
Erythema 146 146
Purulent Discharge 126 126
Low Blood Pressure/ Hypotension 119 119
Heart Failure/Congestive Heart Failure 118 118
Swelling/ Edema 116 116
Shock 110 110
Staphylococcus Aureus 104 104
Fainting 97 97
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 96 96
Palpitations 95 95
Pericardial Effusion 94 94
Congestive Heart Failure 79 79
Weakness 71 71
Loss of consciousness 69 69
Pneumothorax 68 68
Fluid Discharge 66 66
Vascular Dissection 63 63
Inflammation 63 63
Hypersensitivity/Allergic reaction 62 62
Impaired Healing 57 57
Septic Shock 53 53
Pleural Effusion 53 53
Nausea 47 47
Hemorrhage/Bleeding 44 44
Non specific EKG/ECG Changes 44 44
Cardiac Tamponade 41 41
Therapeutic Response, Increased 40 40
Cardiopulmonary Arrest 39 39
Muscle Weakness 38 38
Cardiac Perforation 36 36
Thrombosis 35 35
Stroke/CVA 35 35
Cardiomyopathy 35 35
Drug Resistant Bacterial Infection 34 34
Bruise/Contusion 33 33
Atrial Tachycardia 33 33
Complete Heart Block 33 33
Cardiogenic Shock 31 31
Discharge 31 31
Atrial Flutter 31 31
Pneumonia 30 30
Chills 30 30
Anxiety 30 30
Respiratory Failure 29 29
Myocardial Infarction 29 29
Failure of Implant 28 28
Vomiting 28 28
Pulmonary Edema 26 26
High Blood Pressure/ Hypertension 26 26
Abscess 26 26
Twiddlers Syndrome 26 26
Thrombosis/Thrombus 25 25
Presyncope 24 24
Edema 23 23
Patient Problem/Medical Problem 23 23
Renal Failure 22 22

Recalls
Manufacturer Recall Class Date Posted
1 Abbott II Apr-10-2020
2 Abbott Medical II Sep-19-2023
3 Boston Scientific CRM Corp II May-08-2010
4 Boston Scientific Corporation II Sep-02-2022
5 Boston Scientific Corporation II Nov-08-2017
6 Medtronic Inc. Cardiac Rhythm Disease Managment II Oct-21-2010
7 Medtronic Inc. Cardiac Rhythm Disease Managment II Nov-09-2009
8 Medtronic Inc. Cardiac Rhythm Managment II Jan-28-2009
9 Medtronic Inc., Cardiac Rhythm and Heart Failure II May-19-2017
10 Medtronic Inc., Cardiac Rhythm and Heart Failure II Jan-07-2017
11 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Jun-16-2023
12 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Aug-09-2022
13 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jul-28-2022
14 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jun-14-2022
15 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II May-20-2021
16 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II May-04-2021
17 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Mar-27-2021
18 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jan-26-2021
19 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Feb-01-2018
20 Sorin CRM SAS II Aug-15-2018
21 Sorin Group Italia SRL - CRF II Sep-28-2017
22 St Jude Medical CRMD II May-03-2012
23 St Jude Medical Inc. II Jun-29-2018
24 St Jude Medical Inc. II Jun-12-2018
25 St Jude Medical Inc. I Oct-10-2017
26 St Jude Medical Inc. I Oct-21-2016
27 St. Jude Medical, Cardiac Rhythm Management Division II Apr-21-2022
28 ela Medical Llc II Sep-27-2010
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