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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)
2017 2018 2019 2020 2021 2022
162 142 98 125 111 79

MDR Year MDR Reports MDR Events
2017 18453 18453
2018 17238 17238
2019 16189 16189
2020 16912 16912
2021 19675 19675
2022 19776 19776

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 25266 25266
Adverse Event Without Identified Device or Use Problem 20818 20818
High impedance 18832 18832
Inappropriate/Inadequate Shock/Stimulation 12206 12206
Premature Discharge of Battery 11958 11958
Signal Artifact/Noise 11087 11087
Fracture 8662 8662
Impedance Problem 5804 5804
High Capture Threshold 5747 5747
Device Sensing Problem 4717 4717
Battery Problem 4682 4682
Under-Sensing 3050 3050
Low impedance 3023 3023
Pacing Problem 2920 2920
Device Dislodged or Dislocated 2638 2638
Failure to Capture 2465 2465
Failure to Read Input Signal 2189 2189
Device Displays Incorrect Message 2078 2078
Capturing Problem 2055 2055
Decreased Sensitivity 1825 1825
Defective Device 1626 1626
Incorrect, Inadequate or Imprecise Result or Readings 1519 1519
Inappropriate or Unexpected Reset 1433 1433
Ambient Noise Problem 1420 1420
Premature Elective Replacement Indicator 1335 1335
Break 1234 1234
Mechanical Problem 1173 1173
Device Operates Differently Than Expected 1057 1057
Material Integrity Problem 1014 1014
Appropriate Term/Code Not Available 1014 1014
Failure to Interrogate 989 989
Electrical /Electronic Property Problem 973 973
Failure to Convert Rhythm 947 947
Positioning Failure 880 880
Connection Problem 768 768
Electromagnetic Interference 761 761
Defibrillation/Stimulation Problem 716 716
Noise, Audible 686 686
Device Alarm System 684 684
Activation, Positioning or Separation Problem 657 657
Data Problem 621 621
Communication or Transmission Problem 615 615
Positioning Problem 588 588
Delayed Charge Time 563 563
Invalid Sensing 557 557
Unstable Capture Threshold 486 486
Premature End-of-Life Indicator 409 409
Interrogation Problem 385 385
Failure to Charge 380 380
Failure to Deliver Shock/Stimulation 328 328
Migration 327 327
Failure to Select Signal 322 322
Inaccurate Synchronization 308 308
Migration or Expulsion of Device 301 301
No Apparent Adverse Event 300 300
Reset Problem 264 264
Incorrect Interpretation of Signal 255 255
Unexpected Therapeutic Results 248 248
Difficult to Remove 242 242
Protective Measures Problem 226 226
Intermittent Capture 211 211
Misconnection 210 210
Telemetry Discrepancy 210 210
Insufficient Information 199 199
Patient-Device Incompatibility 199 199
Use of Device Problem 198 198
Unable to Obtain Readings 175 175
Failure to Sense 166 166
Loose or Intermittent Connection 149 149
Incorrect Measurement 142 142
Nonstandard Device 140 140
Output Problem 127 127
Human-Device Interface Problem 113 113
Pacemaker Found in Back-Up Mode 97 97
Device-Device Incompatibility 94 94
Material Twisted/Bent 87 87
Pocket Stimulation 86 86
Difficult to Insert 83 83
Power Problem 83 83
No Audible Alarm 82 82
Collapse 80 80
Off-Label Use 72 72
Environmental Compatibility Problem 66 66
Device Contamination with Body Fluid 63 63
Charging Problem 58 58
Unintended Electrical Shock 58 58
No Pacing 56 56
Material Deformation 54 54
Wireless Communication Problem 53 53
Programming Issue 52 52
Missing Test Results 51 51
Stretched 49 49
Device Contamination with Chemical or Other Material 47 47
High Sensing Threshold 45 45
Low Sensing Threshold 44 44
Pacing Asynchronously 43 43
Energy Output Problem 37 37
Bent 32 32
Premature Activation 31 31
Detachment of Device or Device Component 31 31

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 37645 37645
No Clinical Signs, Symptoms or Conditions 27651 27651
Unspecified Infection 13173 13173
No Consequences Or Impact To Patient 8947 8947
Shock from Patient Lead(s) 5426 5426
Electric Shock 4140 4140
No Code Available 3666 3666
Sepsis 2512 2512
Death 1291 1291
Pocket Erosion 1096 1096
Insufficient Information 1096 1096
Syncope 764 764
Pain 735 735
Ventricular Fibrillation 713 713
Erosion 669 669
Therapeutic Effects, Unexpected 650 650
No Patient Involvement 623 623
Hematoma 583 583
Ventricular Tachycardia 566 566
Dizziness 545 545
Discomfort 517 517
Endocarditis 499 499
Arrhythmia 471 471
Cardiac Perforation 416 416
Bradycardia 415 415
Cardiac Arrest 407 407
Chest Pain 389 389
Complaint, Ill-Defined 389 389
Dyspnea 388 388
Syncope/Fainting 367 367
Bacterial Infection 341 341
Pericardial Effusion 326 326
Twiddlers Syndrome 305 305
Wound Dehiscence 300 300
Atrial Fibrillation 267 267
Tachycardia 256 256
Anxiety 235 235
Fall 229 229
Muscle Stimulation 221 221
Device Overstimulation of Tissue 221 221
Fever 220 220
Perforation 215 215
Swelling 197 197
Staphylococcus Aureus 186 186
No Information 181 181
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 171 171
Purulent Discharge 161 161
Twiddlers Syndrome 158 158
Cardiac Tamponade 155 155
Occlusion 151 151
Distress 150 150
Depression 143 143
Fatigue 124 124
Undesired Nerve Stimulation 123 123
Swelling/ Edema 122 122
Low Blood Pressure/ Hypotension 120 120
Emotional Changes 108 108
Pneumothorax 107 107
Palpitations 105 105
Asystole 102 102
Obstruction/Occlusion 96 96
Hypersensitivity/Allergic reaction 85 85
Non specific EKG/ECG Changes 83 83
Fluid Discharge 81 81
Inflammation 80 80
Impaired Healing 78 78
Erythema 76 76
Thrombosis 75 75
Failure of Implant 73 73
Patient Problem/Medical Problem 72 72
Septic Shock 67 67
Weakness 63 63
Heart Failure 57 57
Pleural Effusion 56 56
Nausea 54 54
Chills 54 54
Shock 52 52
Thrombosis/Thrombus 49 49
Loss of consciousness 47 47
Congestive Heart Failure 43 43
Vomiting 41 41
Post Operative Wound Infection 40 40
Muscle Weakness 40 40
Vascular Dissection 38 38
Discharge 36 36
Stroke/CVA 36 36
Atrial Tachycardia 34 34
Abscess 34 34
Fainting 32 32
Exit Block 32 32
Hemorrhage/Bleeding 31 31
Thrombus 31 31
Heart Failure/Congestive Heart Failure 31 31
Perforation of Vessels 30 30
Burning Sensation 29 29
Pneumonia 29 29
Necrosis 29 29
Bruise/Contusion 29 29
Cardiogenic Shock 28 28
Injury 27 27

Recalls
Manufacturer Recall Class Date Posted
1 BIOTRONIK Inc II Apr-21-2021
2 Boston Scientific Corporation II Sep-02-2022
3 Boston Scientific Corporation II Feb-18-2021
4 Boston Scientific Corporation I Feb-05-2021
5 Boston Scientific Corporation I Jan-19-2021
6 Boston Scientific Corporation II Oct-31-2020
7 Boston Scientific Corporation II Mar-03-2020
8 Boston Scientific Corporation II Sep-13-2019
9 Boston Scientific Corporation II Nov-16-2018
10 Boston Scientific Corporation II Sep-27-2018
11 Boston Scientific Corporation II Sep-27-2018
12 Boston Scientific Corporation II Nov-08-2017
13 Boston Scientific Corporation II Aug-16-2017
14 Boston Scientific Corporation II Feb-09-2017
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 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jul-10-2018
19 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Feb-01-2018
20 St Jude Medical Inc. I Aug-02-2019
21 St Jude Medical Inc. II Jun-29-2018
22 St Jude Medical Inc. I Oct-10-2017
23 St. Jude Medical, Cardiac Rhythm Management Division II Apr-21-2022
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