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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)
2017 2018 2019 2020 2021 2022
112 91 62 75 67 58

MDR Year MDR Reports MDR Events
2017 16260 16260
2018 8341 8341
2019 7263 7263
2020 9610 9610
2021 10137 10137
2022 9043 9043

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 18454 18454
Over-Sensing 13890 13890
Premature Discharge of Battery 5245 5245
High impedance 2930 2930
Inappropriate/Inadequate Shock/Stimulation 2587 2587
Failure to Capture 2318 2318
Battery Problem 2112 2112
Inappropriate or Unexpected Reset 1982 1982
Pacing Problem 1880 1880
Device Dislodged or Dislocated 1767 1767
Device Sensing Problem 1383 1383
Signal Artifact/Noise 1250 1250
Electrical /Electronic Property Problem 1201 1201
Failure to Interrogate 1144 1144
Incorrect Measurement 967 967
Mechanical Problem 779 779
High Capture Threshold 725 725
Under-Sensing 721 721
Capturing Problem 702 702
Defective Device 498 498
Appropriate Term/Code Not Available 489 489
Electromagnetic Interference 486 486
Incorrect Interpretation of Signal 430 430
Device Operates Differently Than Expected 396 396
Low impedance 379 379
Failure to Deliver Shock/Stimulation 376 376
Data Problem 361 361
Communication or Transmission Problem 359 359
Premature Elective Replacement Indicator 344 344
Reset Problem 339 339
Ambient Noise Problem 319 319
Break 317 317
Connection Problem 295 295
Invalid Sensing 284 284
Defibrillation/Stimulation Problem 279 279
Difficult to Remove 276 276
Fracture 262 262
Misconnection 260 260
Unable to Obtain Readings 257 257
Therapy Delivered to Incorrect Body Area 248 248
Impedance Problem 243 243
Device Displays Incorrect Message 239 239
Incorrect, Inadequate or Imprecise Result or Readings 235 235
Migration or Expulsion of Device 226 226
Pacing Asynchronously 218 218
No Pacing 216 216
Failure to Advance 214 214
Failure to Convert Rhythm 212 212
Loose or Intermittent Connection 204 204
Use of Device Problem 197 197
Insufficient Information 178 178
Material Integrity Problem 169 169
Difficult to Insert 160 160
Output Problem 156 156
Environmental Compatibility Problem 155 155
Failure to Charge 145 145
Interrogation Problem 143 143
Delayed Charge Time 142 142
Missing Test Results 140 140
Pacemaker Found in Back-Up Mode 119 119
Inaccurate Synchronization 117 117
Premature End-of-Life Indicator 116 116
Device Alarm System 114 114
Failure to Sense 113 113
No Apparent Adverse Event 109 109
Separation Failure 107 107
Intermittent Capture 105 105
Wireless Communication Problem 105 105
Migration 102 102
Protective Measures Problem 90 90
Pocket Stimulation 90 90
Failure to Disconnect 87 87
Unexpected Therapeutic Results 84 84
Noise, Audible 75 75
Nonstandard Device 71 71
Telemetry Discrepancy 68 68
Off-Label Use 64 64
Detachment of Device or Device Component 58 58
Failure to Read Input Signal 54 54
Compatibility Problem 52 52
Fitting Problem 49 49
Programming Issue 41 41
Program or Algorithm Execution Failure 40 40
Patient-Device Incompatibility 36 36
Decreased Sensitivity 35 35
Defective Alarm 30 30
Pacing Inadequately 29 29
Vibration 29 29
No Device Output 28 28
Component Missing 27 27
Contamination of Device Ingredient or Reagent 27 27
Material Twisted/Bent 25 25
Therapeutic or Diagnostic Output Failure 25 25
Difficult to Interrogate 24 24
Unintended Electrical Shock 23 23
Sensing Intermittently 22 22
Pacing Intermittently 19 19
Charging Problem 19 19
Failure to Select Signal 18 18
Device Contamination with Body Fluid 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 26874 26876
No Clinical Signs, Symptoms or Conditions 14075 14075
Unspecified Infection 7167 7167
No Consequences Or Impact To Patient 3278 3279
Shock from Patient Lead(s) 1334 1334
Sepsis 1117 1117
Death 1112 1112
Pocket Erosion 761 761
No Patient Involvement 744 744
No Code Available 712 712
Discomfort 670 670
Insufficient Information 572 572
Arrhythmia 532 532
Therapeutic Effects, Unexpected 527 527
Hematoma 507 507
Dyspnea 352 352
Erosion 337 337
No Information 335 335
Ventricular Fibrillation 318 318
Dizziness 314 314
Syncope 310 310
Electric Shock 297 297
Ventricular Tachycardia 272 272
Pain 258 258
Bradycardia 252 252
Muscle Stimulation 237 237
Endocarditis 233 233
Tachycardia 198 198
Fatigue 183 183
Cardiac Arrest 175 175
Wound Dehiscence 172 172
Complaint, Ill-Defined 168 168
Syncope/Fainting 162 162
Bacterial Infection 157 157
Fever 147 147
Undesired Nerve Stimulation 147 147
Chest Pain 133 133
Atrial Fibrillation 127 127
Twiddlers Syndrome 123 123
Device Overstimulation of Tissue 108 108
Swelling 107 107
Heart Failure 93 93
Fall 77 77
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 68 68
Palpitations 66 66
Erythema 66 66
Purulent Discharge 65 65
Staphylococcus Aureus 61 61
Low Blood Pressure/ Hypotension 57 57
Heart Failure/Congestive Heart Failure 53 53
Pericardial Effusion 52 52
Congestive Heart Failure 52 52
Asystole 50 50
Pneumothorax 48 48
Weakness 46 46
Swelling/ Edema 45 45
Inflammation 45 45
Vascular Dissection 44 44
Fluid Discharge 42 42
Impaired Healing 37 37
Pleural Effusion 37 37
Septic Shock 33 33
Nausea 33 33
Hypersensitivity/Allergic reaction 28 28
Non specific EKG/ECG Changes 28 28
Fainting 26 26
Discharge 26 26
Complete Heart Block 26 26
Cardiac Tamponade 25 25
Loss of consciousness 25 25
Cardiomyopathy 25 25
Cardiopulmonary Arrest 25 25
Hemorrhage/Bleeding 23 23
Vomiting 23 23
Cardiac Perforation 22 22
Atrial Tachycardia 22 22
Chills 21 21
Cardiogenic Shock 20 20
Thrombosis 20 20
Shock 19 19
Pneumonia 19 19
Pulmonary Edema 19 19
High Blood Pressure/ Hypertension 19 19
Muscle Weakness 19 19
Stroke/CVA 19 19
Bruise/Contusion 19 19
Atrial Flutter 18 18
Edema 15 15
Myocardial Infarction 15 15
Abscess 14 14
Anxiety 13 13
Twiddlers Syndrome 13 13
Chest Tightness/Pressure 12 12
Post Operative Wound Infection 12 12
Numbness 11 11
Pulmonary Embolism 11 11
Cellulitis 11 11
Necrosis 11 11
Hypoxia 10 10
Renal Failure 10 10

Recalls
Manufacturer Recall Class Date Posted
1 Abbott II Apr-10-2020
2 Boston Scientific Corporation II Sep-02-2022
3 Boston Scientific Corporation II Nov-08-2017
4 Medtronic Inc., Cardiac Rhythm and Heart Failure II May-19-2017
5 Medtronic Inc., Cardiac Rhythm and Heart Failure II Jan-07-2017
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 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Feb-01-2018
14 Sorin CRM SAS II Aug-15-2018
15 Sorin Group Italia SRL - CRF II Sep-28-2017
16 St Jude Medical Inc. II Jun-29-2018
17 St Jude Medical Inc. II Jun-12-2018
18 St Jude Medical Inc. I Oct-10-2017
19 St. Jude Medical, Cardiac Rhythm Management Division II Apr-21-2022
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