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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)
2016 2017 2018 2019 2020 2021
145 162 142 98 125 84

MDR Year MDR Reports MDR Events
2016 16635 16635
2017 18454 18454
2018 17237 17237
2019 16188 16188
2020 16912 16912
2021 14632 14632

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 23388 23388
Adverse Event Without Identified Device or Use Problem 20938 20938
High impedance 17820 17820
Inappropriate/Inadequate Shock/Stimulation 10700 10700
Signal Artifact/Noise 9056 9056
Fracture 8244 8244
Premature Discharge of Battery 7492 7492
Impedance Problem 5497 5497
High Capture Threshold 5234 5234
Device Sensing Problem 4035 4035
Device Displays Incorrect Message 2804 2804
Under-Sensing 2792 2792
Pacing Problem 2653 2653
Low impedance 2646 2646
Device Dislodged or Dislocated 2445 2445
Battery Problem 2433 2433
Failure to Capture 2343 2343
Capturing Problem 2200 2200
Ambient Noise Problem 2081 2081
Device Operates Differently Than Expected 1761 1761
Inappropriate or Unexpected Reset 1557 1557
Decreased Sensitivity 1465 1465
Mechanical Problem 1188 1188
Break 1177 1177
Failure to Interrogate 1175 1175
Failure to Read Input Signal 1153 1153
Defective Device 1070 1070
Material Integrity Problem 1059 1059
Appropriate Term/Code Not Available 1018 1018
Electrical /Electronic Property Problem 985 985
Positioning Failure 944 944
Connection Problem 914 914
Invalid Sensing 910 910
Premature Elective Replacement Indicator 856 856
Defibrillation/Stimulation Problem 837 837
Failure to Convert Rhythm 830 830
Device Alarm System 823 823
Activation, Positioning or SeparationProblem 677 677
Delayed Charge Time 677 677
Electromagnetic Interference 664 664
Communication or Transmission Problem 662 662
Positioning Problem 567 567
Nonstandard Device 511 511
Data Problem 476 476
Unstable Capture Threshold 460 460
Incorrect, Inadequate or Imprecise Resultor Readings 376 376
Noise, Audible 347 347
Migration or Expulsion of Device 339 339
Premature End-of-Life Indicator 333 333
Failure to Select Signal 323 323
Failure to Charge 320 320
Reset Problem 262 262
Protective Measures Problem 258 258
Interrogation Problem 241 241
Migration 220 220
Misconnection 216 216
Difficult to Remove 215 215
Intermittent Capture 209 209
Failure to Deliver Shock/Stimulation 199 199
Insufficient Information 198 198
Output Problem 198 198
Patient-Device Incompatibility 184 184
Unable to Obtain Readings 183 183
Inaccurate Synchronization 183 183
Incorrect Interpretation of Signal 177 177
Loose or Intermittent Connection 174 174
No Apparent Adverse Event 169 169
Failure to Sense 162 162
Unexpected Therapeutic Results 158 158
Telemetry Discrepancy 151 151
Human-Device Interface Problem 144 144
Incorrect Measurement 133 133
Pacemaker Found in Back-Up Mode 125 125
Use of Device Problem 107 107
Charging Problem 101 101
Device-Device Incompatibility 98 98
Pocket Stimulation 91 91
Collapse 83 83
Difficult to Interrogate 69 69
Difficult to Insert 68 68
Device Contamination with Body Fluid 65 65
Programming Issue 63 63
Wireless Communication Problem 63 63
No Audible Alarm 63 63
Fitting Problem 61 61
Unintended Electrical Shock 57 57
Material Twisted/Bent 56 56
Missing Test Results 55 55
Material Deformation 54 54
No Pacing 53 53
Off-Label Use 53 53
Power Problem 51 51
High Sensing Threshold 47 47
Low Sensing Threshold 44 44
Stretched 44 44
Bent 44 44
Device Damaged by Another Device 42 42
False Alarm 40 40
Arcing 37 37
Device Contamination with Chemical or Other Material 36 36

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 48283 48284
Unspecified Infection 11384 11384
No Consequences Or Impact To Patient 10497 10497
No Clinical Signs, Symptoms or Conditions 10323 10323
Shock from Patient Lead(s) 5792 5792
No Code Available 3750 3750
Sepsis 2029 2029
Electric Shock 1913 1913
Death 1647 1648
Syncope 955 955
Pocket Erosion 883 883
Insufficient Information 883 883
Ventricular Tachycardia 777 777
Pain 721 721
No Patient Involvement 720 720
Ventricular Fibrillation 714 714
Erosion 674 674
Therapeutic Effects, Unexpected 656 656
Hematoma 556 556
Complaint, Ill-Defined 539 539
Dizziness 530 530
Endocarditis 504 504
Cardiac Arrest 432 432
Cardiac Perforation 429 429
Discomfort 390 390
Dyspnea 385 385
Chest Pain 374 374
Device Overstimulation of Tissue 367 367
Bradycardia 350 350
Twiddlers Syndrome 341 341
Pericardial Effusion 320 320
Atrial Fibrillation 318 318
Arrhythmia 296 296
Muscle Stimulation 271 271
Wound Dehiscence 265 265
Swelling 232 232
Bacterial Infection 222 222
Anxiety 218 218
Fall 215 215
Staphylococcus Aureus 215 215
No Information 209 209
Fever 207 207
Perforation 167 167
Occlusion 164 164
Syncope/Fainting 161 161
Cardiac Tamponade 155 155
Distress 154 154
Palpitations 145 145
Tachycardia 144 144
Depression 142 142
Fatigue 142 142
Low Blood Pressure/ Hypotension 122 122
Purulent Discharge 118 118
Undesired Nerve Stimulation 118 118
Pneumothorax 115 115
Emotional Changes 104 104
Patient Problem/Medical Problem 100 100
Thrombosis 97 97
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 92 92
Heart Failure 83 83
Non specific EKG/ECG Changes 80 80
Inflammation 79 79
Weakness 79 79
Failure of Implant 69 69
Impaired Healing 67 67
Hypersensitivity/Allergic reaction 66 66
Nausea 65 65
Septic Shock 64 64
Fainting 57 57
Twiddlers Syndrome 56 56
Congestive Heart Failure 54 54
Pleural Effusion 54 54
Erythema 53 53
Post Operative Wound Infection 48 48
Thrombus 46 46
Shock 45 45
Exit Block 44 44
Discharge 43 43
Atrial Tachycardia 42 42
Obstruction/Occlusion 42 42
Stroke/CVA 42 42
Vomiting 41 41
Loss of consciousness 41 41
Chills 40 40
Perforation of Vessels 39 39
Vascular Dissection 37 37
Cardiomyopathy 37 37
Fluid Discharge 36 36
Cardiogenic Shock 36 36
Swelling/ Edema 34 34
Atrial Flutter 33 33
Abscess 33 33
Asystole 32 32
Seizures 32 32
Edema 32 32
Myocardial Infarction 32 32
Hemorrhage/Bleeding 31 31
Complete Heart Block 30 30
Pneumonia 29 29
Burning Sensation 29 29

Recalls
Manufacturer Recall Class Date Posted
1 BIOTRONIK Inc II Apr-21-2021
2 Boston Scientific Corporation II Feb-18-2021
3 Boston Scientific Corporation I Feb-05-2021
4 Boston Scientific Corporation I Jan-19-2021
5 Boston Scientific Corporation II Oct-31-2020
6 Boston Scientific Corporation II Mar-03-2020
7 Boston Scientific Corporation II Sep-13-2019
8 Boston Scientific Corporation II Nov-16-2018
9 Boston Scientific Corporation II Sep-27-2018
10 Boston Scientific Corporation II Sep-27-2018
11 Boston Scientific Corporation II Nov-08-2017
12 Boston Scientific Corporation II Aug-16-2017
13 Boston Scientific Corporation II Feb-09-2017
14 Medtronic Inc., Cardiac Rhythm and Heart Failure II Aug-25-2016
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 Cardiac Rhythm Management Division I Jan-21-2016
19 St Jude Medical Inc. I Aug-02-2019
20 St Jude Medical Inc. II Jun-29-2018
21 St Jude Medical Inc. I Oct-10-2017
22 St Jude Medical Inc. I Oct-21-2016
23 St Jude Medical Inc. II May-10-2016
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