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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 3

MDR Year MDR Reports MDR Events
2018 8344 8344
2019 7264 7264
2020 9610 9610
2021 10137 10137
2022 10658 10658

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 11853 11853
Adverse Event Without Identified Device or Use Problem 9303 9303
Premature Discharge of Battery 4091 4091
High impedance 2591 2591
Inappropriate/Inadequate Shock/Stimulation 2232 2232
Failure to Capture 2166 2166
Battery Problem 1818 1818
Inappropriate or Unexpected Reset 1753 1753
Device Dislodged or Dislocated 1733 1733
Pacing Problem 1719 1719
Device Sensing Problem 1384 1384
Signal Artifact/Noise 1233 1233
Electrical /Electronic Property Problem 1067 1067
Failure to Interrogate 1044 1044
Incorrect Measurement 951 951
High Capture Threshold 687 687
Under-Sensing 653 653
Mechanical Problem 631 631
Capturing Problem 612 612
Defective Device 515 515
Electromagnetic Interference 496 496
Appropriate Term/Code Not Available 493 493
Incorrect Interpretation of Signal 438 438
Failure to Deliver Shock/Stimulation 391 391
Data Problem 370 370
Low impedance 342 342
Reset Problem 328 328
Break 324 324
Communication or Transmission Problem 313 313
Premature Elective Replacement Indicator 284 284
Therapy Delivered to Incorrect Body Area 267 267
Difficult to Remove 254 254
Incorrect, Inadequate or Imprecise Result or Readings 250 250
Unable to Obtain Readings 241 241
Connection Problem 239 239
Pacing Asynchronously 231 231
Failure to Advance 223 223
Loose or Intermittent Connection 209 209
Misconnection 206 206
Failure to Convert Rhythm 204 204
Defibrillation/Stimulation Problem 204 204
No Pacing 200 200
Impedance Problem 198 198
Fracture 196 196
Ambient Noise Problem 188 188
Migration or Expulsion of Device 185 185
Use of Device Problem 183 183
Insufficient Information 176 176
Environmental Compatibility Problem 169 169
Interrogation Problem 151 151
Material Integrity Problem 144 144
Device Displays Incorrect Message 141 141
Difficult to Insert 139 139
Failure to Charge 139 139
Missing Test Results 138 138
Inaccurate Synchronization 125 125
No Apparent Adverse Event 116 116
Device Operates Differently Than Expected 111 111
Separation Failure 111 111
Failure to Sense 109 109
Premature End-of-Life Indicator 109 109
Migration 107 107
Output Problem 105 105
Intermittent Capture 98 98
Failure to Disconnect 97 97
Invalid Sensing 95 95
Wireless Communication Problem 94 94
Unexpected Therapeutic Results 82 82
Delayed Charge Time 79 79
Noise, Audible 77 77
Protective Measures Problem 72 72
Pacemaker Found in Back-Up Mode 72 72
Pocket Stimulation 70 70
Off-Label Use 68 68
Detachment of Device or Device Component 63 63
Device Alarm System 61 61
Failure to Read Input Signal 60 60
Compatibility Problem 55 55
Nonstandard Device 52 52
Telemetry Discrepancy 47 47
Program or Algorithm Execution Failure 40 40
Fitting Problem 38 38
Patient-Device Incompatibility 36 36
Contamination of Device Ingredient or Reagent 31 31
Material Twisted/Bent 28 28
Component Missing 25 25
Defective Alarm 23 23
Unintended Electrical Shock 23 23
Failure to Select Signal 17 17
Sensing Intermittently 17 17
Charging Problem 17 17
Decreased Sensitivity 17 17
Device Contamination with Body Fluid 16 16
Product Quality Problem 16 16
Pacing Intermittently 14 14
Difficult to Interrogate 14 14
Display or Visual Feedback Problem 14 14
Application Program Version or Upgrade Problem 14 14
Therapeutic or Diagnostic Output Failure 14 14
Programming Issue 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15194 15194
No Known Impact Or Consequence To Patient 13360 13362
Unspecified Infection 6708 6708
No Consequences Or Impact To Patient 2972 2973
Shock from Patient Lead(s) 1049 1049
Sepsis 951 951
Pocket Erosion 723 723
No Code Available 693 693
Discomfort 682 682
Death 664 664
No Patient Involvement 648 648
Insufficient Information 608 608
Arrhythmia 554 554
Therapeutic Effects, Unexpected 453 453
Hematoma 394 394
Electric Shock 319 319
Erosion 304 304
Dyspnea 298 298
No Information 297 297
Dizziness 257 257
Ventricular Fibrillation 257 257
Bradycardia 243 243
Pain 209 209
Syncope 205 205
Tachycardia 199 199
Ventricular Tachycardia 196 196
Endocarditis 193 193
Muscle Stimulation 177 177
Syncope/Fainting 177 177
Bacterial Infection 166 166
Wound Dehiscence 156 156
Fatigue 147 147
Undesired Nerve Stimulation 134 134
Fever 124 124
Complaint, Ill-Defined 121 121
Cardiac Arrest 116 116
Twiddlers Syndrome 100 100
Chest Pain 99 99
Atrial Fibrillation 99 99
Swelling 78 78
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 78 78
Erythema 66 66
Fall 63 63
Purulent Discharge 62 62
Heart Failure/Congestive Heart Failure 59 59
Asystole 58 58
Device Overstimulation of Tissue 58 58
Swelling/ Edema 51 51
Pericardial Effusion 47 47
Staphylococcus Aureus 47 47
Palpitations 46 46
Low Blood Pressure/ Hypotension 45 45
Fluid Discharge 44 44
Heart Failure 43 43
Vascular Dissection 42 42
Inflammation 40 40
Pneumothorax 38 38
Impaired Healing 33 33
Weakness 31 31
Pleural Effusion 30 30
Non specific EKG/ECG Changes 28 28
Septic Shock 26 26
Hypersensitivity/Allergic reaction 25 25
Nausea 24 24
Congestive Heart Failure 22 22
Cardiopulmonary Arrest 22 22
Cardiac Tamponade 22 22
Cardiac Perforation 22 22
Discharge 21 21
Hemorrhage/Bleeding 20 20
Muscle Weakness 20 20
Cardiogenic Shock 19 19
Complete Heart Block 19 19
Loss of consciousness 18 18
Vomiting 18 18
Chills 16 16
Cardiomyopathy 15 15
Bruise/Contusion 15 15
Atrial Tachycardia 14 14
Stroke/CVA 14 14
Drug Resistant Bacterial Infection 14 14
Twiddlers Syndrome 13 13
Abscess 13 13
High Blood Pressure/ Hypertension 13 13
Shock 13 13
Pulmonary Edema 13 13
Anxiety 12 12
Pneumonia 11 11
Hypoxia 11 11
Edema 11 11
Cellulitis 11 11
Atrial Flutter 10 10
Itching Sensation 10 10
Presyncope 10 10
Implant Pain 9 9
Myocardial Infarction 9 9
Pulmonary Embolism 9 9
Necrosis 8 8
Failure of Implant 8 8
Perforation 8 8

Recalls
Manufacturer Recall Class Date Posted
1 Abbott II Apr-10-2020
2 Boston Scientific Corporation II Sep-02-2022
3 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Aug-09-2022
4 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jul-28-2022
5 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jun-14-2022
6 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II May-20-2021
7 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II May-04-2021
8 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Mar-27-2021
9 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jan-26-2021
10 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Feb-01-2018
11 Sorin CRM SAS II Aug-15-2018
12 St Jude Medical Inc. II Jun-29-2018
13 St Jude Medical Inc. II Jun-12-2018
14 St. Jude Medical, Cardiac Rhythm Management Division II Apr-21-2022
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