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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)
2018 2019 2020 2021 2022 2023
142 98 125 111 91 80

MDR Year MDR Reports MDR Events
2018 17229 17229
2019 16186 16186
2020 16910 16910
2021 19659 19659
2022 23463 23463
2023 24391 24391

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 27849 27849
High impedance 19871 19871
Adverse Event Without Identified Device or Use Problem 18807 18807
Premature Discharge of Battery 15129 15129
Inappropriate/Inadequate Shock/Stimulation 14570 14570
Signal Artifact/Noise 13482 13482
Fracture 9043 9043
Impedance Problem 6743 6743
High Capture Threshold 6400 6400
Device Sensing Problem 5621 5621
Battery Problem 5426 5426
Incorrect, Inadequate or Imprecise Result or Readings 4054 4054
Under-Sensing 3945 3945
Pacing Problem 3609 3609
Low impedance 3480 3480
Failure to Read Input Signal 3477 3477
Device Dislodged or Dislocated 2894 2894
Failure to Capture 2686 2686
Defective Device 2171 2171
Decreased Sensitivity 2154 2154
Capturing Problem 2021 2021
Premature Elective Replacement Indicator 1854 1854
Inappropriate or Unexpected Reset 1311 1311
Device Displays Incorrect Message 1299 1299
Break 1283 1283
Noise, Audible 1231 1231
Mechanical Problem 1180 1180
Appropriate Term/Code Not Available 1174 1174
Failure to Convert Rhythm 1075 1075
Material Integrity Problem 1015 1015
Electrical /Electronic Property Problem 965 965
Failure to Interrogate 926 926
Electromagnetic Interference 896 896
Connection Problem 831 831
Data Problem 814 814
Ambient Noise Problem 779 779
Defibrillation/Stimulation Problem 710 710
Positioning Failure 692 692
Positioning Problem 611 611
Activation, Positioning or Separation Problem 608 608
Insufficient Information 587 587
Interrogation Problem 542 542
Unstable Capture Threshold 536 536
Premature End-of-Life Indicator 509 509
Inaccurate Synchronization 482 482
Migration 477 477
Delayed Charge Time 476 476
Failure to Deliver Shock/Stimulation 472 472
Nonstandard Device 471 471
Communication or Transmission Problem 470 470
Device Alarm System 462 462
Device Operates Differently Than Expected 437 437
No Apparent Adverse Event 431 431
Failure to Charge 400 400
Unexpected Therapeutic Results 346 346
Failure to Select Signal 321 321
Use of Device Problem 321 321
Incorrect Interpretation of Signal 321 321
Therapeutic or Diagnostic Output Failure 296 296
Reset Problem 271 271
Migration or Expulsion of Device 245 245
Difficult to Remove 240 240
Invalid Sensing 240 240
Telemetry Discrepancy 239 239
Protective Measures Problem 225 225
Intermittent Capture 217 217
Patient-Device Incompatibility 214 214
Misconnection 203 203
Unable to Obtain Readings 178 178
Loose or Intermittent Connection 163 163
Failure to Sense 162 162
Incorrect Measurement 158 158
Environmental Compatibility Problem 149 149
Output Problem 128 128
Material Twisted/Bent 119 119
Power Problem 117 117
Off-Label Use 111 111
Human-Device Interface Problem 99 99
No Audible Alarm 98 98
Difficult to Insert 95 95
Device-Device Incompatibility 92 92
No Pacing 85 85
High Sensing Threshold 79 79
Pocket Stimulation 78 78
Collapse 76 76
Device Contamination with Body Fluid 68 68
Product Quality Problem 59 59
Unintended Electrical Shock 58 58
Pacing Asynchronously 57 57
Stretched 52 52
Missing Test Results 52 52
Device Contamination with Chemical or Other Material 52 52
Defective Component 51 51
Material Deformation 46 46
Charging Problem 46 46
Low Sensing Threshold 42 42
Energy Output Problem 42 42
Display or Visual Feedback Problem 39 39
Premature Activation 39 39
Wireless Communication Problem 36 36

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 44217 44217
No Known Impact Or Consequence To Patient 25256 25256
Unspecified Infection 14854 14854
No Consequences Or Impact To Patient 7340 7340
Electric Shock 7010 7010
Shock from Patient Lead(s) 5504 5504
No Code Available 3632 3632
Insufficient Information 3441 3441
Sepsis 2424 2424
Pocket Erosion 1255 1255
Death 813 813
Ventricular Fibrillation 802 802
Pain 772 772
Discomfort 695 695
Erosion 686 686
Arrhythmia 678 678
Syncope/Fainting 610 610
Dizziness 608 608
Hematoma 587 587
Syncope 554 554
Bradycardia 538 538
Therapeutic Effects, Unexpected 521 521
Endocarditis 519 519
Bacterial Infection 516 516
No Patient Involvement 479 479
Chest Pain 457 457
Dyspnea 454 454
Tachycardia 439 439
Cardiac Perforation 438 438
Cardiac Arrest 414 414
Ventricular Tachycardia 402 402
Wound Dehiscence 341 341
Pericardial Effusion 339 339
Complaint, Ill-Defined 273 273
Fever 258 258
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 258 258
Twiddlers Syndrome 257 257
Perforation 256 256
Anxiety 256 256
Foreign Body In Patient 252 252
Twiddlers Syndrome 249 249
Fall 246 246
Swelling/ Edema 238 238
Purulent Discharge 229 229
Atrial Fibrillation 227 227
Asystole 198 198
No Information 166 166
Cardiac Tamponade 165 165
Muscle Stimulation 165 165
Obstruction/Occlusion 161 161
Device Overstimulation of Tissue 160 160
Staphylococcus Aureus 155 155
Distress 148 148
Undesired Nerve Stimulation 144 144
Swelling 140 140
Fluid Discharge 140 140
Occlusion 139 139
Low Blood Pressure/ Hypotension 139 139
Failure of Implant 139 139
Depression 138 138
Erythema 132 132
Fatigue 122 122
Hypersensitivity/Allergic reaction 109 109
Emotional Changes 106 106
Pneumothorax 98 98
Impaired Healing 98 98
Inflammation 86 86
Thrombosis/Thrombus 86 86
Non specific EKG/ECG Changes 84 84
Palpitations 75 75
Septic Shock 74 74
Loss of consciousness 71 71
Drug Resistant Bacterial Infection 67 67
Heart Failure/Congestive Heart Failure 66 66
Presyncope 64 64
Muscle Weakness 64 64
Chills 62 62
Thrombosis 55 55
Shock 53 53
Pleural Effusion 52 52
Nausea 52 52
Hemorrhage/Bleeding 48 48
Abscess 48 48
Weakness 48 48
Heart Block 47 47
Vomiting 45 45
Heart Failure 42 42
Stroke/CVA 42 42
Patient Problem/Medical Problem 40 40
Vascular Dissection 38 38
Unspecified Heart Problem 38 38
Weight Changes 36 36
Necrosis 35 35
Implant Pain 35 35
Burning Sensation 34 34
Bruise/Contusion 32 32
Cardiogenic Shock 31 31
Pneumonia 29 29
Atrial Tachycardia 27 27
Stenosis 27 27

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 Aug-22-2023
4 Boston Scientific Corporation II Mar-03-2023
5 Boston Scientific Corporation II Sep-02-2022
6 Boston Scientific Corporation II Feb-18-2021
7 Boston Scientific Corporation I Feb-05-2021
8 Boston Scientific Corporation I Jan-19-2021
9 Boston Scientific Corporation II Oct-31-2020
10 Boston Scientific Corporation II Mar-03-2020
11 Boston Scientific Corporation II Sep-13-2019
12 Boston Scientific Corporation II Nov-16-2018
13 Boston Scientific Corporation II Sep-27-2018
14 Boston Scientific Corporation II Sep-27-2018
15 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Jun-16-2023
16 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Aug-09-2022
17 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jun-14-2022
18 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Mar-27-2021
19 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jul-10-2018
20 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Feb-01-2018
21 St Jude Medical Inc. I Aug-02-2019
22 St Jude Medical Inc. II Jun-29-2018
23 St. Jude Medical, Cardiac Rhythm Management Division II Apr-21-2022
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