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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)
2018 2019 2020 2021 2022 2023
91 62 75 67 62 36

MDR Year MDR Reports MDR Events
2018 8347 8347
2019 7265 7265
2020 9609 9609
2021 10134 10134
2022 10646 10646
2023 8150 8150

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 14269 14269
Adverse Event Without Identified Device or Use Problem 10643 10643
Premature Discharge of Battery 4498 4498
High impedance 3078 3078
Inappropriate/Inadequate Shock/Stimulation 2726 2726
Failure to Capture 2615 2615
Pacing Problem 2293 2293
Device Dislodged or Dislocated 1995 1995
Inappropriate or Unexpected Reset 1936 1936
Battery Problem 1897 1897
Device Sensing Problem 1623 1623
Signal Artifact/Noise 1536 1536
Failure to Interrogate 1349 1349
Electrical /Electronic Property Problem 1175 1175
Incorrect Measurement 1048 1048
Under-Sensing 883 883
High Capture Threshold 808 808
Capturing Problem 741 741
Mechanical Problem 740 740
Defective Device 663 663
Appropriate Term/Code Not Available 593 593
Electromagnetic Interference 586 586
Incorrect Interpretation of Signal 562 562
Failure to Deliver Shock/Stimulation 488 488
Low impedance 435 435
Break 413 413
Data Problem 409 409
Therapy Delivered to Incorrect Body Area 339 339
Premature Elective Replacement Indicator 334 334
Reset Problem 333 333
Incorrect, Inadequate or Imprecise Result or Readings 332 332
Insufficient Information 331 331
Communication or Transmission Problem 328 328
Pacing Asynchronously 305 305
Failure to Advance 297 297
Connection Problem 290 290
Difficult to Remove 283 283
Loose or Intermittent Connection 283 283
Impedance Problem 279 279
Failure to Convert Rhythm 262 262
Unable to Obtain Readings 258 258
Defibrillation/Stimulation Problem 249 249
Environmental Compatibility Problem 245 245
Fracture 243 243
No Pacing 236 236
Misconnection 228 228
Use of Device Problem 217 217
Migration or Expulsion of Device 215 215
Ambient Noise Problem 194 194
Interrogation Problem 189 189
Inaccurate Synchronization 175 175
No Apparent Adverse Event 164 164
Failure to Charge 160 160
Material Integrity Problem 153 153
Difficult to Insert 150 150
Missing Test Results 144 144
Separation Failure 143 143
Device Displays Incorrect Message 141 141
Failure to Sense 135 135
Premature End-of-Life Indicator 132 132
Migration 123 123
Output Problem 123 123
Failure to Read Input Signal 122 122
Nonstandard Device 121 121
Wireless Communication Problem 117 117
Failure to Disconnect 116 116
Intermittent Capture 112 112
Device Operates Differently Than Expected 111 111
Noise, Audible 107 107
Unexpected Therapeutic Results 99 99
Delayed Charge Time 98 98
Invalid Sensing 95 95
Off-Label Use 86 86
Pacemaker Found in Back-Up Mode 84 84
Protective Measures Problem 79 79
Detachment of Device or Device Component 76 76
Pocket Stimulation 72 72
Device Alarm System 68 68
Compatibility Problem 66 66
Telemetry Discrepancy 56 56
Contamination of Device Ingredient or Reagent 48 48
Therapeutic or Diagnostic Output Failure 45 45
Program or Algorithm Execution Failure 44 44
Fitting Problem 40 40
Patient-Device Incompatibility 36 36
Material Twisted/Bent 33 33
Unintended Electrical Shock 28 28
Component Missing 28 28
Product Quality Problem 28 28
Display or Visual Feedback Problem 24 24
Defective Alarm 23 23
Charging Problem 22 22
Device Contamination with Body Fluid 19 19
Pacing Intermittently 19 19
Tactile Prompts/Feedback 19 19
Positioning Problem 19 19
Sensing Intermittently 18 18
Failure to Select Signal 17 17
Decreased Sensitivity 17 17
High Sensing Threshold 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20515 20515
No Known Impact Or Consequence To Patient 13359 13361
Unspecified Infection 7779 7779
No Consequences Or Impact To Patient 2972 2973
Shock from Patient Lead(s) 1213 1213
Insufficient Information 1197 1197
Sepsis 1019 1019
Pocket Erosion 859 859
Discomfort 839 839
Arrhythmia 730 730
No Code Available 693 693
Death 664 664
No Patient Involvement 648 648
Electric Shock 461 461
Therapeutic Effects, Unexpected 453 453
Hematoma 439 439
Dyspnea 334 334
Erosion 328 328
Bradycardia 316 316
Ventricular Fibrillation 313 313
No Information 297 297
Dizziness 296 296
Tachycardia 268 268
Syncope/Fainting 252 252
Pain 249 249
Endocarditis 221 221
Bacterial Infection 217 217
Syncope 205 205
Wound Dehiscence 201 201
Ventricular Tachycardia 196 196
Muscle Stimulation 177 177
Fatigue 167 167
Fever 152 152
Undesired Nerve Stimulation 145 145
Cardiac Arrest 131 131
Complaint, Ill-Defined 121 121
Chest Pain 109 109
Atrial Fibrillation 109 109
Asystole 105 105
Twiddlers Syndrome 100 100
Heart Failure/Congestive Heart Failure 95 95
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 90 90
Erythema 88 88
Device Overstimulation of Tissue 84 84
Swelling 78 78
Purulent Discharge 78 78
Fall 78 78
Swelling/ Edema 73 73
Low Blood Pressure/ Hypotension 67 67
Fluid Discharge 58 58
Pericardial Effusion 56 56
Inflammation 48 48
Staphylococcus Aureus 47 47
Palpitations 46 46
Vascular Dissection 45 45
Heart Failure 43 43
Impaired Healing 38 38
Pneumothorax 38 38
Septic Shock 33 33
Hypersensitivity/Allergic reaction 32 32
Muscle Weakness 32 32
Pleural Effusion 32 32
Non specific EKG/ECG Changes 32 32
Weakness 31 31
Hemorrhage/Bleeding 29 29
Cardiac Perforation 29 29
Cardiac Tamponade 27 27
Nausea 26 26
Drug Resistant Bacterial Infection 25 25
Congestive Heart Failure 22 22
Cardiopulmonary Arrest 22 22
Discharge 21 21
Cardiogenic Shock 21 21
Twiddlers Syndrome 20 20
Stroke/CVA 20 20
Vomiting 20 20
Chills 19 19
Presyncope 19 19
Loss of consciousness 19 19
Complete Heart Block 19 19
Anxiety 18 18
Bruise/Contusion 18 18
Abscess 18 18
Failure of Implant 17 17
High Blood Pressure/ Hypertension 16 16
Thrombosis/Thrombus 16 16
Pulmonary Edema 15 15
Cardiomyopathy 15 15
Atrial Tachycardia 14 14
Pneumonia 14 14
Shock 14 14
Heart Block 14 14
Implant Pain 13 13
Respiratory Failure 12 12
Myocardial Infarction 12 12
Hypoxia 11 11
Itching Sensation 11 11
Cellulitis 11 11
Pulmonary Embolism 11 11
Atrial Flutter 11 11

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., 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 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Feb-01-2018
13 Sorin CRM SAS II Aug-15-2018
14 St Jude Medical Inc. II Jun-29-2018
15 St Jude Medical Inc. II Jun-12-2018
16 St. Jude Medical, Cardiac Rhythm Management Division II Apr-21-2022
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