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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 4

MDR Year MDR Reports MDR Events
2019 7265 7265
2020 9609 9609
2021 10134 10134
2022 10646 10646
2023 11898 11898
2024 973 973

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 13726 13726
Adverse Event Without Identified Device or Use Problem 9265 9265
Premature Discharge of Battery 3871 3871
High impedance 2815 2815
Inappropriate/Inadequate Shock/Stimulation 2703 2703
Failure to Capture 2665 2665
Pacing Problem 2510 2510
Device Dislodged or Dislocated 1986 1986
Inappropriate or Unexpected Reset 1679 1679
Device Sensing Problem 1678 1678
Signal Artifact/Noise 1575 1575
Failure to Interrogate 1396 1396
Battery Problem 1224 1224
Incorrect Measurement 1068 1068
Electrical /Electronic Property Problem 1042 1042
Under-Sensing 930 930
High Capture Threshold 807 807
Capturing Problem 723 723
Defective Device 696 696
Mechanical Problem 624 624
Electromagnetic Interference 614 614
Incorrect Interpretation of Signal 592 592
Appropriate Term/Code Not Available 557 557
Failure to Deliver Shock/Stimulation 546 546
Break 442 442
Low impedance 439 439
Therapy Delivered to Incorrect Body Area 389 389
Incorrect, Inadequate or Imprecise Result or Readings 376 376
Data Problem 370 370
Pacing Asynchronously 359 359
Failure to Advance 335 335
Reset Problem 333 333
Loose or Intermittent Connection 329 329
Premature Elective Replacement Indicator 323 323
Insufficient Information 315 315
Environmental Compatibility Problem 301 301
Failure to Convert Rhythm 288 288
Difficult to Remove 283 283
Connection Problem 268 268
Impedance Problem 266 266
Unable to Obtain Readings 247 247
Communication or Transmission Problem 236 236
No Pacing 229 229
Interrogation Problem 224 224
Fracture 223 223
Inaccurate Synchronization 220 220
Use of Device Problem 209 209
Migration or Expulsion of Device 204 204
Misconnection 198 198
Defibrillation/Stimulation Problem 198 198
Failure to Read Input Signal 172 172
No Apparent Adverse Event 165 165
Separation Failure 159 159
Failure to Charge 147 147
Difficult to Insert 145 145
Failure to Sense 144 144
Missing Test Results 143 143
Failure to Disconnect 126 126
Migration 124 124
Wireless Communication Problem 121 121
Premature End-of-Life Indicator 120 120
Unexpected Therapeutic Results 114 114
Output Problem 114 114
Material Integrity Problem 107 107
Noise, Audible 106 106
Intermittent Capture 105 105
Off-Label Use 95 95
Delayed Charge Time 85 85
Detachment of Device or Device Component 83 83
Pacemaker Found in Back-Up Mode 81 81
Nonstandard Device 74 74
Compatibility Problem 74 74
Product Quality Problem 63 63
Device Displays Incorrect Message 63 63
Protective Measures Problem 61 61
Contamination of Device Ingredient or Reagent 54 54
Pocket Stimulation 54 54
Program or Algorithm Execution Failure 48 48
Telemetry Discrepancy 41 41
Therapeutic or Diagnostic Output Failure 39 39
Material Twisted/Bent 38 38
Device Alarm System 37 37
Patient-Device Incompatibility 34 34
Fitting Problem 28 28
Unintended Electrical Shock 28 28
Charging Problem 24 24
Display or Visual Feedback Problem 23 23
Component Missing 22 22
Tactile Prompts/Feedback 20 20
Pacing Intermittently 19 19
Device Contamination with Body Fluid 17 17
Sensing Intermittently 17 17
Failure to Select Signal 17 17
Difficult to Advance 16 16
Use of Incorrect Control/Treatment Settings 16 16
Defective Alarm 16 16
Positioning Problem 16 16
Defective Component 15 15
Application Program Freezes, Becomes Nonfunctional 14 14
Material Split, Cut or Torn 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23706 23706
No Known Impact Or Consequence To Patient 8277 8278
Unspecified Infection 7222 7222
No Consequences Or Impact To Patient 2531 2532
Insufficient Information 1309 1309
Shock from Patient Lead(s) 1136 1136
Discomfort 919 919
Sepsis 847 847
Arrhythmia 842 842
Pocket Erosion 825 825
No Code Available 656 656
Electric Shock 580 580
No Patient Involvement 467 467
Death 408 408
Hematoma 372 372
Bradycardia 338 338
Tachycardia 325 325
Ventricular Fibrillation 306 306
Syncope/Fainting 305 305
Therapeutic Effects, Unexpected 300 300
Dyspnea 289 289
Erosion 282 282
Dizziness 267 267
Pain 230 230
Bacterial Infection 224 224
Wound Dehiscence 211 211
Endocarditis 187 187
Fever 150 150
Asystole 139 139
Fatigue 137 137
Muscle Stimulation 128 128
Undesired Nerve Stimulation 127 127
Ventricular Tachycardia 126 126
No Information 122 122
Cardiac Arrest 118 118
Syncope 112 112
Heart Failure/Congestive Heart Failure 110 110
Erythema 109 109
Chest Pain 107 107
Swelling/ Edema 104 104
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 95 95
Purulent Discharge 94 94
Device Overstimulation of Tissue 92 92
Atrial Fibrillation 89 89
Twiddlers Syndrome 80 80
Low Blood Pressure/ Hypotension 70 70
Fall 68 68
Fluid Discharge 61 61
Swelling 52 52
Pericardial Effusion 48 48
Vascular Dissection 44 44
Complaint, Ill-Defined 44 44
Impaired Healing 39 39
Muscle Weakness 36 36
Inflammation 35 35
Non specific EKG/ECG Changes 33 33
Hypersensitivity/Allergic reaction 31 31
Pneumothorax 31 31
Drug Resistant Bacterial Infection 31 31
Staphylococcus Aureus 30 30
Septic Shock 29 29
Cardiac Perforation 29 29
Palpitations 26 26
Pleural Effusion 26 26
Nausea 26 26
Hemorrhage/Bleeding 26 26
Stroke/CVA 24 24
Loss of consciousness 24 24
Twiddlers Syndrome 24 24
Thrombosis/Thrombus 23 23
Heart Failure 23 23
Presyncope 22 22
Cardiac Tamponade 21 21
Weakness 21 21
Abscess 20 20
Failure of Implant 19 19
Chills 18 18
Cardiogenic Shock 18 18
Vomiting 18 18
Anxiety 17 17
Heart Block 16 16
Discharge 16 16
Bruise/Contusion 14 14
Implant Pain 13 13
Complete Heart Block 13 13
Respiratory Failure 12 12
Congestive Heart Failure 12 12
Cardiopulmonary Arrest 11 11
High Blood Pressure/ Hypertension 11 11
Pulmonary Edema 11 11
Unspecified Heart Problem 11 11
Necrosis 10 10
Myocardial Infarction 10 10
Cellulitis 10 10
Atrial Tachycardia 9 9
Pulmonary Embolism 9 9
Edema 9 9
Itching Sensation 9 9
Pneumonia 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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