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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implantable cardioverter defibrillator (non-crt)
Definition These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.
Product CodeLWS
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
98 125 111 91 101 23

MDR Year MDR Reports MDR Events
2019 16186 16186
2020 16910 16910
2021 19659 19659
2022 23463 23463
2023 28724 28724
2024 6418 6418

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 26331 26331
High impedance 17825 17825
Adverse Event Without Identified Device or Use Problem 17331 17331
Premature Discharge of Battery 15493 15493
Inappropriate/Inadequate Shock/Stimulation 14839 14839
Signal Artifact/Noise 13404 13404
Fracture 8102 8102
Impedance Problem 6267 6267
High Capture Threshold 6151 6151
Device Sensing Problem 5671 5671
Battery Problem 5132 5132
Incorrect, Inadequate or Imprecise Result or Readings 5055 5055
Failure to Read Input Signal 4112 4112
Under-Sensing 4103 4103
Pacing Problem 3780 3780
Low impedance 3314 3314
Device Dislodged or Dislocated 2717 2717
Failure to Capture 2466 2466
Defective Device 2289 2289
Decreased Sensitivity 2108 2108
Premature Elective Replacement Indicator 2007 2007
Capturing Problem 1717 1717
Noise, Audible 1319 1319
Failure to Convert Rhythm 1091 1091
Break 1085 1085
Appropriate Term/Code Not Available 1061 1061
Inappropriate or Unexpected Reset 1053 1053
Mechanical Problem 1010 1010
Electromagnetic Interference 909 909
Material Integrity Problem 885 885
Data Problem 857 857
Electrical /Electronic Property Problem 852 852
Failure to Interrogate 757 757
Connection Problem 751 751
Defibrillation/Stimulation Problem 594 594
Interrogation Problem 589 589
Positioning Problem 585 585
Insufficient Information 575 575
Failure to Deliver Shock/Stimulation 574 574
Inaccurate Synchronization 565 565
Premature End-of-Life Indicator 527 527
Unstable Capture Threshold 515 515
Migration 515 515
Positioning Failure 512 512
No Apparent Adverse Event 497 497
Activation, Positioning or Separation Problem 480 480
Unexpected Therapeutic Results 379 379
Delayed Charge Time 366 366
Nonstandard Device 364 364
Failure to Charge 339 339
Use of Device Problem 326 326
Incorrect Interpretation of Signal 311 311
Therapeutic or Diagnostic Output Failure 293 293
Failure to Select Signal 292 292
Communication or Transmission Problem 241 241
Device Displays Incorrect Message 237 237
Reset Problem 235 235
Telemetry Discrepancy 231 231
Device Alarm System 226 226
Difficult to Remove 218 218
Patient-Device Incompatibility 194 194
Intermittent Capture 193 193
Environmental Compatibility Problem 186 186
Migration or Expulsion of Device 176 176
Misconnection 175 175
Unable to Obtain Readings 154 154
Incorrect Measurement 150 150
Protective Measures Problem 147 147
Loose or Intermittent Connection 138 138
Failure to Sense 137 137
Power Problem 131 131
Material Twisted/Bent 120 120
Off-Label Use 117 117
Output Problem 98 98
No Audible Alarm 96 96
Difficult to Insert 90 90
Device-Device Incompatibility 82 82
No Pacing 79 79
Pocket Stimulation 69 69
Pacing Asynchronously 66 66
Human-Device Interface Problem 65 65
Collapse 62 62
Device Contamination with Body Fluid 62 62
Product Quality Problem 57 57
Unintended Electrical Shock 55 55
Missing Test Results 51 51
Device Contamination with Chemical or Other Material 47 47
Stretched 45 45
Defective Component 45 45
High Sensing Threshold 40 40
Ambient Noise Problem 39 39
Premature Activation 39 39
Difficult to Fold, Unfold or Collapse 38 38
Compatibility Problem 38 38
Material Deformation 37 37
Energy Output Problem 35 35
Contamination /Decontamination Problem 32 32
Detachment of Device or Device Component 31 31
Charging Problem 29 29
Low Sensing Threshold 29 29

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 50809 50809
No Known Impact Or Consequence To Patient 15071 15071
Unspecified Infection 14047 14047
Electric Shock 7851 7851
Shock from Patient Lead(s) 5755 5755
No Consequences Or Impact To Patient 5410 5410
Insufficient Information 3561 3561
No Code Available 3469 3469
Sepsis 2099 2099
Pocket Erosion 1168 1168
Ventricular Fibrillation 769 769
Discomfort 764 764
Arrhythmia 764 764
Syncope/Fainting 740 740
Pain 733 733
Erosion 633 633
Dizziness 575 575
Bradycardia 571 571
Bacterial Infection 560 560
Tachycardia 540 540
Hematoma 502 502
Endocarditis 463 463
Chest Pain 449 449
Death 443 443
Dyspnea 418 418
Cardiac Perforation 414 414
Cardiac Arrest 379 379
Wound Dehiscence 353 353
Syncope 342 342
Pericardial Effusion 312 312
Swelling/ Edema 309 309
Twiddlers Syndrome 286 286
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 277 277
No Patient Involvement 277 277
Therapeutic Effects, Unexpected 273 273
Purulent Discharge 259 259
Perforation 258 258
Foreign Body In Patient 257 257
Fever 255 255
Asystole 249 249
Fall 225 225
Ventricular Tachycardia 224 224
Erythema 190 190
Obstruction/Occlusion 186 186
Twiddlers Syndrome 177 177
Atrial Fibrillation 166 166
Device Overstimulation of Tissue 165 165
Fluid Discharge 153 153
Cardiac Tamponade 143 143
Low Blood Pressure/ Hypotension 137 137
Undesired Nerve Stimulation 127 127
Anxiety 125 125
Complaint, Ill-Defined 116 116
Failure of Implant 114 114
Impaired Healing 103 103
Hypersensitivity/Allergic reaction 102 102
Emotional Changes 102 102
Muscle Stimulation 99 99
Fatigue 97 97
Staphylococcus Aureus 97 97
Thrombosis/Thrombus 96 96
Swelling 88 88
Heart Failure/Congestive Heart Failure 87 87
Loss of consciousness 83 83
Occlusion 82 82
Drug Resistant Bacterial Infection 81 81
Non specific EKG/ECG Changes 80 80
Pneumothorax 77 77
Presyncope 76 76
No Information 75 75
Muscle Weakness 75 75
Inflammation 73 73
Septic Shock 71 71
Heart Block 58 58
Chills 56 56
Hemorrhage/Bleeding 49 49
Nausea 48 48
Palpitations 48 48
Abscess 47 47
Shock 46 46
Pleural Effusion 46 46
Unspecified Heart Problem 46 46
Implant Pain 45 45
Vomiting 45 45
Weight Changes 43 43
Vascular Dissection 36 36
Burning Sensation 36 36
Stroke/CVA 36 36
Thrombosis 32 32
Skin Inflammation/ Irritation 30 30
Bruise/Contusion 28 28
Weakness 28 28
Necrosis 27 27
Cardiogenic Shock 26 26
Calcium Deposits/Calcification 24 24
Cellulitis 23 23
Pneumonia 23 23
Tricuspid Valve Insufficiency/ Regurgitation 23 23
Perforation of Vessels 22 22
Stenosis 21 21

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical II Sep-19-2023
2 BIOTRONIK Inc II Apr-21-2021
3 Boston Scientific Corporation II Jan-05-2024
4 Boston Scientific Corporation II Aug-22-2023
5 Boston Scientific Corporation II Mar-03-2023
6 Boston Scientific Corporation II Sep-02-2022
7 Boston Scientific Corporation II Feb-18-2021
8 Boston Scientific Corporation I Feb-05-2021
9 Boston Scientific Corporation I Jan-19-2021
10 Boston Scientific Corporation II Oct-31-2020
11 Boston Scientific Corporation II Mar-03-2020
12 Boston Scientific Corporation II Sep-13-2019
13 Medtronic Inc. II Jan-22-2024
14 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Jun-16-2023
15 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Aug-09-2022
16 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jun-14-2022
17 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Mar-27-2021
18 St Jude Medical Inc. I Aug-02-2019
19 St. Jude Medical, Cardiac Rhythm Management Division II Apr-21-2022
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