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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 10

MDR Year MDR Reports MDR Events
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
Over-Sensing 14322 14322
Adverse Event Without Identified Device or Use Problem 9558 9558
Premature Discharge of Battery 3943 3943
High impedance 2919 2919
Inappropriate/Inadequate Shock/Stimulation 2860 2860
Failure to Capture 2803 2803
Pacing Problem 2690 2690
Device Dislodged or Dislocated 2061 2061
Device Sensing Problem 1782 1782
Inappropriate or Unexpected Reset 1722 1722
Signal Artifact/Noise 1652 1652
Failure to Interrogate 1523 1523
Battery Problem 1243 1243
Electrical /Electronic Property Problem 1085 1085
Incorrect Measurement 1079 1079
Under-Sensing 989 989
High Capture Threshold 842 842
Capturing Problem 755 755
Defective Device 724 724
Mechanical Problem 639 639
Electromagnetic Interference 624 624
Incorrect Interpretation of Signal 623 623
Failure to Deliver Shock/Stimulation 578 578
Appropriate Term/Code Not Available 577 577
Low impedance 460 460
Break 451 451
Therapy Delivered to Incorrect Body Area 412 412
Data Problem 395 395
Incorrect, Inadequate or Imprecise Result or Readings 390 390
Pacing Asynchronously 386 386
Loose or Intermittent Connection 349 349
Failure to Advance 344 344
Premature Elective Replacement Indicator 342 342
Reset Problem 334 334
Insufficient Information 324 324
Environmental Compatibility Problem 318 318
Failure to Convert Rhythm 300 300
Difficult to Remove 286 286
Impedance Problem 278 278
Connection Problem 277 277
Unable to Obtain Readings 249 249
Communication or Transmission Problem 246 246
No Pacing 236 236
Inaccurate Synchronization 233 233
Fracture 232 232
Interrogation Problem 230 230
Migration or Expulsion of Device 220 220
Use of Device Problem 219 219
Misconnection 207 207
Defibrillation/Stimulation Problem 204 204
Failure to Read Input Signal 202 202
No Apparent Adverse Event 178 178
Separation Failure 174 174
Failure to Charge 155 155
Failure to Sense 151 151
Difficult to Insert 147 147
Missing Test Results 146 146
Wireless Communication Problem 132 132
Failure to Disconnect 130 130
Premature End-of-Life Indicator 128 128
Migration 126 126
Output Problem 118 118
Unexpected Therapeutic Results 117 117
Material Integrity Problem 109 109
Intermittent Capture 109 109
Noise, Audible 108 108
Off-Label Use 97 97
Delayed Charge Time 90 90
Detachment of Device or Device Component 88 88
Pacemaker Found in Back-Up Mode 85 85
Compatibility Problem 76 76
Nonstandard Device 74 74
Product Quality Problem 64 64
Device Displays Incorrect Message 63 63
Protective Measures Problem 63 63
Pocket Stimulation 59 59
Contamination of Device Ingredient or Reagent 57 57
Program or Algorithm Execution Failure 49 49
Telemetry Discrepancy 45 45
Material Twisted/Bent 40 40
Therapeutic or Diagnostic Output Failure 39 39
Device Alarm System 37 37
Patient-Device Incompatibility 34 34
Unintended Electrical Shock 29 29
Fitting Problem 28 28
Display or Visual Feedback Problem 25 25
Charging Problem 24 24
Component Missing 24 24
Tactile Prompts/Feedback 20 20
Pacing Intermittently 19 19
Sensing Intermittently 18 18
Difficult to Advance 17 17
Failure to Select Signal 17 17
Device Contamination with Body Fluid 17 17
Defective Alarm 16 16
Positioning Problem 16 16
Use of Incorrect Control/Treatment Settings 16 16
Defective Component 15 15
Application Program Freezes, Becomes Nonfunctional 15 15
Decreased Sensitivity 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25059 25059
No Known Impact Or Consequence To Patient 8277 8278
Unspecified Infection 7452 7452
No Consequences Or Impact To Patient 2531 2532
Insufficient Information 1351 1351
Shock from Patient Lead(s) 1235 1235
Discomfort 974 974
Arrhythmia 885 885
Sepsis 862 862
Pocket Erosion 856 856
No Code Available 656 656
Electric Shock 585 585
No Patient Involvement 467 467
Death 408 408
Hematoma 384 384
Bradycardia 359 359
Tachycardia 354 354
Syncope/Fainting 327 327
Ventricular Fibrillation 323 323
Dyspnea 303 303
Therapeutic Effects, Unexpected 300 300
Erosion 289 289
Dizziness 281 281
Pain 240 240
Bacterial Infection 237 237
Wound Dehiscence 224 224
Endocarditis 194 194
Fever 159 159
Asystole 156 156
Fatigue 150 150
Erythema 129 129
Muscle Stimulation 128 128
Undesired Nerve Stimulation 127 127
Ventricular Tachycardia 126 126
Cardiac Arrest 122 122
No Information 122 122
Heart Failure/Congestive Heart Failure 116 116
Swelling/ Edema 116 116
Syncope 112 112
Chest Pain 110 110
Purulent Discharge 104 104
Device Overstimulation of Tissue 99 99
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 96 96
Atrial Fibrillation 89 89
Twiddlers Syndrome 80 80
Low Blood Pressure/ Hypotension 74 74
Fall 71 71
Fluid Discharge 63 63
Pericardial Effusion 52 52
Swelling 52 52
Vascular Dissection 47 47
Complaint, Ill-Defined 44 44
Impaired Healing 41 41
Muscle Weakness 37 37
Inflammation 36 36
Drug Resistant Bacterial Infection 34 34
Non specific EKG/ECG Changes 33 33
Hypersensitivity/Allergic reaction 33 33
Septic Shock 32 32
Pneumothorax 31 31
Staphylococcus Aureus 30 30
Cardiac Perforation 29 29
Pleural Effusion 27 27
Hemorrhage/Bleeding 27 27
Nausea 26 26
Palpitations 26 26
Loss of consciousness 26 26
Twiddlers Syndrome 26 26
Thrombosis/Thrombus 25 25
Stroke/CVA 25 25
Presyncope 24 24
Heart Failure 23 23
Failure of Implant 22 22
Cardiac Tamponade 21 21
Weakness 21 21
Abscess 20 20
Vomiting 19 19
Chills 19 19
Cardiogenic Shock 19 19
Anxiety 18 18
Heart Block 17 17
Discharge 16 16
Implant Pain 14 14
Bruise/Contusion 14 14
Complete Heart Block 13 13
Respiratory Failure 12 12
Unspecified Heart Problem 12 12
Congestive Heart Failure 12 12
High Blood Pressure/ Hypertension 12 12
Cardiopulmonary Arrest 11 11
Cellulitis 11 11
Necrosis 11 11
Pulmonary Edema 11 11
Pneumonia 10 10
Myocardial Infarction 10 10
Malaise 10 10
Foreign Body In Patient 10 10
Skin Inflammation/ Irritation 9 9
Itching Sensation 9 9
Shock 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., 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
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