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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 15

MDR Year MDR Reports MDR Events
2018 17238 17238
2019 16189 16189
2020 16912 16912
2021 19675 19675
2022 23503 23503
2023 3881 3881

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 23089 23089
High impedance 17054 17054
Adverse Event Without Identified Device or Use Problem 16155 16155
Premature Discharge of Battery 12471 12471
Inappropriate/Inadequate Shock/Stimulation 11542 11542
Signal Artifact/Noise 10862 10862
Fracture 7916 7916
High Capture Threshold 5451 5451
Impedance Problem 5393 5393
Battery Problem 4867 4867
Device Sensing Problem 4674 4674
Under-Sensing 3029 3029
Low impedance 2861 2861
Pacing Problem 2737 2737
Device Dislodged or Dislocated 2480 2480
Failure to Read Input Signal 2467 2467
Incorrect, Inadequate or Imprecise Result or Readings 2320 2320
Failure to Capture 2265 2265
Defective Device 1816 1816
Decreased Sensitivity 1775 1775
Capturing Problem 1728 1728
Premature Elective Replacement Indicator 1451 1451
Device Displays Incorrect Message 1292 1292
Inappropriate or Unexpected Reset 1153 1153
Break 1095 1095
Mechanical Problem 1020 1020
Appropriate Term/Code Not Available 986 986
Material Integrity Problem 901 901
Failure to Convert Rhythm 865 865
Noise, Audible 860 860
Electrical /Electronic Property Problem 859 859
Failure to Interrogate 813 813
Electromagnetic Interference 773 773
Ambient Noise Problem 757 757
Connection Problem 668 668
Data Problem 657 657
Positioning Failure 649 649
Defibrillation/Stimulation Problem 571 571
Activation, Positioning or Separation Problem 550 550
Positioning Problem 508 508
Unstable Capture Threshold 451 451
Device Operates Differently Than Expected 437 437
Delayed Charge Time 434 434
Device Alarm System 434 434
Communication or Transmission Problem 432 432
Interrogation Problem 432 432
Premature End-of-Life Indicator 421 421
Failure to Charge 367 367
Inaccurate Synchronization 363 363
Failure to Deliver Shock/Stimulation 360 360
Migration 360 360
No Apparent Adverse Event 334 334
Failure to Select Signal 320 320
Unexpected Therapeutic Results 269 269
Incorrect Interpretation of Signal 261 261
Reset Problem 248 248
Invalid Sensing 240 240
Migration or Expulsion of Device 215 215
Use of Device Problem 206 206
Difficult to Remove 203 203
Insufficient Information 202 202
Telemetry Discrepancy 201 201
Patient-Device Incompatibility 197 197
Protective Measures Problem 188 188
Misconnection 187 187
Intermittent Capture 183 183
Unable to Obtain Readings 150 150
Failure to Sense 143 143
Loose or Intermittent Connection 136 136
Incorrect Measurement 124 124
Nonstandard Device 120 120
Material Twisted/Bent 99 99
Power Problem 96 96
Human-Device Interface Problem 94 94
Environmental Compatibility Problem 83 83
Device-Device Incompatibility 82 82
Difficult to Insert 82 82
No Audible Alarm 81 81
Off-Label Use 81 81
Output Problem 77 77
Pocket Stimulation 71 71
Collapse 70 70
Device Contamination with Body Fluid 58 58
Unintended Electrical Shock 58 58
Missing Test Results 46 46
No Pacing 46 46
Device Contamination with Chemical or Other Material 46 46
Stretched 46 46
Pacing Asynchronously 46 46
Material Deformation 43 43
Charging Problem 41 41
High Sensing Threshold 41 41
Low Sensing Threshold 37 37
Energy Output Problem 36 36
Wireless Communication Problem 33 33
Detachment of Device or Device Component 31 31
Premature Activation 31 31
Contamination /Decontamination Problem 30 30
Deformation Due to Compressive Stress 29 29
Improper or Incorrect Procedure or Method 29 29

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 32917 32917
No Known Impact Or Consequence To Patient 25261 25261
Unspecified Infection 12678 12678
No Consequences Or Impact To Patient 7343 7343
Electric Shock 4771 4771
Shock from Patient Lead(s) 4716 4716
No Code Available 3632 3632
Sepsis 2264 2264
Insufficient Information 1158 1158
Pocket Erosion 1109 1109
Death 813 813
Ventricular Fibrillation 650 650
Pain 632 632
Erosion 611 611
Syncope 554 554
Discomfort 534 534
Therapeutic Effects, Unexpected 521 521
Dizziness 516 516
Hematoma 505 505
No Patient Involvement 479 479
Arrhythmia 474 474
Endocarditis 454 454
Syncope/Fainting 427 427
Bradycardia 419 419
Ventricular Tachycardia 402 402
Bacterial Infection 379 379
Cardiac Perforation 370 370
Dyspnea 369 369
Chest Pain 359 359
Cardiac Arrest 348 348
Tachycardia 302 302
Pericardial Effusion 295 295
Wound Dehiscence 279 279
Complaint, Ill-Defined 273 273
Twiddlers Syndrome 249 249
Anxiety 232 232
Perforation 227 227
Fall 205 205
Fever 197 197
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 196 196
Twiddlers Syndrome 195 195
Atrial Fibrillation 192 192
No Information 167 167
Muscle Stimulation 165 165
Purulent Discharge 165 165
Staphylococcus Aureus 155 155
Swelling/ Edema 152 152
Distress 144 144
Cardiac Tamponade 142 142
Swelling 141 141
Occlusion 139 139
Depression 138 138
Asystole 127 127
Obstruction/Occlusion 118 118
Device Overstimulation of Tissue 118 118
Undesired Nerve Stimulation 107 107
Fatigue 106 106
Emotional Changes 102 102
Low Blood Pressure/ Hypotension 102 102
Fluid Discharge 96 96
Pneumothorax 89 89
Hypersensitivity/Allergic reaction 81 81
Impaired Healing 79 79
Erythema 77 77
Non specific EKG/ECG Changes 76 76
Inflammation 76 76
Palpitations 75 75
Failure of Implant 70 70
Thrombosis/Thrombus 64 64
Septic Shock 61 61
Thrombosis 55 55
Loss of consciousness 50 50
Weakness 48 48
Nausea 48 48
Pleural Effusion 47 47
Chills 47 47
Muscle Weakness 45 45
Heart Failure/Congestive Heart Failure 45 45
Heart Failure 42 42
Patient Problem/Medical Problem 40 40
Shock 40 40
Vomiting 38 38
Abscess 37 37
Drug Resistant Bacterial Infection 35 35
Presyncope 34 34
Stroke/CVA 33 33
Hemorrhage/Bleeding 33 33
Necrosis 32 32
Vascular Dissection 31 31
Heart Block 30 30
Atrial Tachycardia 27 27
Cardiogenic Shock 26 26
Implant Pain 26 26
Discharge 25 25
Stenosis 24 24
Bruise/Contusion 24 24
Injury 23 23
Perforation of Vessels 23 23
Burning Sensation 22 22
Pneumonia 22 22

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