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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 32

MDR Year MDR Reports MDR Events
2018 17238 17238
2019 16189 16189
2020 16912 16912
2021 19675 19675
2022 23504 23504
2023 7803 7803

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 24075 24075
High impedance 17619 17619
Adverse Event Without Identified Device or Use Problem 16678 16678
Premature Discharge of Battery 13179 13179
Inappropriate/Inadequate Shock/Stimulation 12154 12154
Signal Artifact/Noise 11369 11369
Fracture 8131 8131
High Capture Threshold 5673 5673
Impedance Problem 5595 5595
Battery Problem 5045 5045
Device Sensing Problem 4868 4868
Under-Sensing 3218 3218
Low impedance 2981 2981
Pacing Problem 2904 2904
Incorrect, Inadequate or Imprecise Result or Readings 2717 2717
Failure to Read Input Signal 2651 2651
Device Dislodged or Dislocated 2559 2559
Failure to Capture 2345 2345
Defective Device 1889 1889
Decreased Sensitivity 1862 1862
Capturing Problem 1802 1802
Premature Elective Replacement Indicator 1555 1555
Device Displays Incorrect Message 1292 1292
Inappropriate or Unexpected Reset 1198 1198
Break 1130 1130
Mechanical Problem 1066 1066
Appropriate Term/Code Not Available 1031 1031
Noise, Audible 949 949
Material Integrity Problem 930 930
Failure to Convert Rhythm 916 916
Electrical /Electronic Property Problem 904 904
Failure to Interrogate 840 840
Electromagnetic Interference 793 793
Ambient Noise Problem 757 757
Connection Problem 736 736
Data Problem 681 681
Positioning Failure 657 657
Defibrillation/Stimulation Problem 605 605
Activation, Positioning or Separation Problem 568 568
Positioning Problem 536 536
Unstable Capture Threshold 472 472
Interrogation Problem 452 452
Communication or Transmission Problem 444 444
Delayed Charge Time 444 444
Device Alarm System 441 441
Device Operates Differently Than Expected 437 437
Premature End-of-Life Indicator 430 430
Migration 389 389
Failure to Deliver Shock/Stimulation 386 386
Inaccurate Synchronization 382 382
Failure to Charge 378 378
No Apparent Adverse Event 354 354
Failure to Select Signal 320 320
Unexpected Therapeutic Results 289 289
Incorrect Interpretation of Signal 276 276
Reset Problem 254 254
Invalid Sensing 240 240
Migration or Expulsion of Device 220 220
Use of Device Problem 218 218
Difficult to Remove 215 215
Telemetry Discrepancy 210 210
Insufficient Information 208 208
Patient-Device Incompatibility 200 200
Protective Measures Problem 191 191
Misconnection 189 189
Intermittent Capture 189 189
Unable to Obtain Readings 156 156
Failure to Sense 146 146
Loose or Intermittent Connection 144 144
Incorrect Measurement 130 130
Nonstandard Device 120 120
Material Twisted/Bent 104 104
Environmental Compatibility Problem 101 101
Power Problem 98 98
Human-Device Interface Problem 96 96
Off-Label Use 85 85
Difficult to Insert 84 84
Device-Device Incompatibility 84 84
No Audible Alarm 82 82
Output Problem 78 78
Pocket Stimulation 73 73
Collapse 72 72
Device Contamination with Body Fluid 64 64
Unintended Electrical Shock 58 58
Stretched 48 48
Pacing Asynchronously 47 47
Missing Test Results 47 47
No Pacing 47 47
Device Contamination with Chemical or Other Material 46 46
Material Deformation 44 44
Charging Problem 41 41
High Sensing Threshold 41 41
Low Sensing Threshold 37 37
Energy Output Problem 36 36
Wireless Communication Problem 36 36
Premature Activation 33 33
Detachment of Device or Device Component 31 31
Contamination /Decontamination Problem 30 30
Difficult to Fold, Unfold or Collapse 30 30
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 35517 35517
No Known Impact Or Consequence To Patient 25261 25261
Unspecified Infection 13114 13114
No Consequences Or Impact To Patient 7343 7343
Electric Shock 5235 5235
Shock from Patient Lead(s) 4867 4867
No Code Available 3632 3632
Sepsis 2286 2286
Insufficient Information 1181 1181
Pocket Erosion 1127 1127
Death 813 813
Ventricular Fibrillation 686 686
Pain 658 658
Erosion 625 625
Discomfort 566 566
Syncope 554 554
Dizziness 529 529
Hematoma 521 521
Therapeutic Effects, Unexpected 521 521
Arrhythmia 511 511
No Patient Involvement 479 479
Syncope/Fainting 466 466
Endocarditis 466 466
Bradycardia 449 449
Bacterial Infection 402 402
Ventricular Tachycardia 402 402
Cardiac Perforation 385 385
Dyspnea 384 384
Chest Pain 382 382
Cardiac Arrest 367 367
Tachycardia 322 322
Pericardial Effusion 306 306
Wound Dehiscence 288 288
Complaint, Ill-Defined 273 273
Twiddlers Syndrome 249 249
Anxiety 241 241
Perforation 234 234
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 217 217
Fall 214 214
Fever 207 207
Atrial Fibrillation 204 204
Twiddlers Syndrome 203 203
Purulent Discharge 172 172
No Information 167 167
Muscle Stimulation 165 165
Swelling/ Edema 164 164
Staphylococcus Aureus 155 155
Cardiac Tamponade 147 147
Distress 145 145
Swelling 141 141
Asystole 141 141
Occlusion 139 139
Depression 138 138
Obstruction/Occlusion 129 129
Device Overstimulation of Tissue 122 122
Fatigue 110 110
Undesired Nerve Stimulation 109 109
Low Blood Pressure/ Hypotension 107 107
Emotional Changes 104 104
Fluid Discharge 102 102
Pneumothorax 91 91
Hypersensitivity/Allergic reaction 88 88
Impaired Healing 82 82
Inflammation 79 79
Erythema 79 79
Non specific EKG/ECG Changes 77 77
Palpitations 75 75
Failure of Implant 70 70
Thrombosis/Thrombus 69 69
Septic Shock 61 61
Loss of consciousness 56 56
Thrombosis 55 55
Chills 50 50
Weakness 48 48
Nausea 48 48
Muscle Weakness 47 47
Pleural Effusion 47 47
Heart Failure/Congestive Heart Failure 47 47
Drug Resistant Bacterial Infection 47 47
Shock 45 45
Heart Failure 42 42
Abscess 41 41
Patient Problem/Medical Problem 40 40
Presyncope 39 39
Vomiting 39 39
Heart Block 37 37
Stroke/CVA 34 34
Hemorrhage/Bleeding 34 34
Necrosis 33 33
Vascular Dissection 31 31
Implant Pain 28 28
Atrial Tachycardia 27 27
Cardiogenic Shock 26 26
Unspecified Heart Problem 26 26
Discharge 25 25
Bruise/Contusion 25 25
Stenosis 24 24
Burning Sensation 24 24
Perforation of Vessels 23 23
Injury 23 23

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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