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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 36

MDR Year MDR Reports MDR Events
2016 16636 16636
2017 18454 18454
2018 17238 17238
2019 16189 16189
2020 16912 16912
2021 7347 7347

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 21729 21729
Adverse Event Without Identified Device or Use Problem 19737 19737
High impedance 16566 16566
Inappropriate/Inadequate Shock/Stimulation 9861 9861
Signal Artifact/Noise 8136 8136
Fracture 7636 7636
Premature Discharge of Battery 6432 6432
Impedance Problem 5017 5017
High Capture Threshold 4852 4852
Device Sensing Problem 3734 3734
Device Displays Incorrect Message 2804 2804
Under-Sensing 2576 2576
Pacing Problem 2443 2443
Low impedance 2441 2441
Device Dislodged or Dislocated 2255 2255
Failure to Capture 2188 2188
Ambient Noise Problem 2080 2080
Capturing Problem 2053 2053
Battery Problem 2040 2040
Device Operates Differently Than Expected 1761 1761
Inappropriate or Unexpected Reset 1480 1480
Decreased Sensitivity 1296 1296
Mechanical Problem 1120 1120
Failure to Interrogate 1114 1114
Break 1099 1099
Material Integrity Problem 1000 1000
Appropriate Term/Code Not Available 949 949
Electrical /Electronic Property Problem 949 949
Failure to Read Input Signal 922 922
Positioning Failure 916 916
Defective Device 911 911
Invalid Sensing 910 910
Connection Problem 866 866
Defibrillation/Stimulation Problem 820 820
Device Alarm System 806 806
Failure to Convert Rhythm 768 768
Delayed Charge Time 660 660
Communication or Transmission Problem 654 654
Activation, Positioning or SeparationProblem 644 644
Electromagnetic Interference 592 592
Premature Elective Replacement Indicator 578 578
Positioning Problem 531 531
Nonstandard Device 510 510
Data Problem 446 446
Unstable Capture Threshold 434 434
Migration or Expulsion of Device 328 328
Failure to Select Signal 323 323
Noise, Audible 313 313
Incorrect, Inadequate or Imprecise Resultor Readings 311 311
Failure to Charge 297 297
Premature End-of-Life Indicator 295 295
Protective Measures Problem 250 250
Reset Problem 238 238
Interrogation Problem 218 218
Difficult to Remove 207 207
Intermittent Capture 197 197
Migration 197 197
Output Problem 195 195
Misconnection 195 195
Insufficient Information 181 181
Patient-Device Incompatibility 181 181
Unable to Obtain Readings 175 175
Loose or Intermittent Connection 168 168
Failure to Deliver Shock/Stimulation 167 167
Incorrect Interpretation of Signal 166 166
Failure to Sense 153 153
Unexpected Therapeutic Results 144 144
Inaccurate Synchronization 137 137
Telemetry Discrepancy 137 137
Human-Device Interface Problem 136 136
No Apparent Adverse Event 135 135
Incorrect Measurement 128 128
Pacemaker Found in Back-Up Mode 123 123
Device-Device Incompatibility 95 95
Charging Problem 95 95
Use of Device Problem 89 89
Pocket Stimulation 86 86
Collapse 79 79
Difficult to Interrogate 69 69
Difficult to Insert 63 63
Programming Issue 63 63
Wireless Communication Problem 63 63
Fitting Problem 61 61
No Audible Alarm 60 60
Unintended Electrical Shock 57 57
Device Contamination with Body Fluid 55 55
No Pacing 51 51
Material Twisted/Bent 49 49
Material Deformation 49 49
High Sensing Threshold 47 47
Off-Label Use 47 47
Missing Test Results 46 46
Low Sensing Threshold 44 44
Bent 44 44
Device Damaged by Another Device 42 42
Power Problem 41 41
Stretched 40 40
False Alarm 38 38
Arcing 37 37
Vibration 35 35

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 48282 48283
No Consequences Or Impact To Patient 10499 10499
Unspecified Infection 10428 10428
Shock from Patient Lead(s) 5425 5425
No Clinical Signs, Symptoms or Conditions 5108 5108
No Code Available 3749 3749
Sepsis 1866 1866
Death 1647 1648
Electric Shock 1505 1505
Syncope 955 955
Pocket Erosion 797 797
Ventricular Tachycardia 777 777
No Patient Involvement 720 720
Pain 687 687
Ventricular Fibrillation 661 661
Therapeutic Effects, Unexpected 656 656
Erosion 630 630
Complaint, Ill-Defined 539 539
Hematoma 533 533
Insufficient Information 527 527
Dizziness 499 499
Endocarditis 469 469
Cardiac Arrest 404 404
Cardiac Perforation 393 393
Dyspnea 364 364
Chest Pain 349 349
Device Overstimulation of Tissue 342 342
Twiddlers Syndrome 341 341
Discomfort 335 335
Atrial Fibrillation 314 314
Bradycardia 305 305
Pericardial Effusion 299 299
Muscle Stimulation 271 271
Arrhythmia 251 251
Wound Dehiscence 243 243
Swelling 232 232
Staphylococcus Aureus 215 215
Anxiety 214 214
No Information 209 209
Fall 208 208
Fever 197 197
Bacterial Infection 187 187
Occlusion 164 164
Perforation 153 153
Distress 153 153
Cardiac Tamponade 150 150
Palpitations 145 145
Depression 142 142
Fatigue 139 139
Low Blood Pressure/ Hypotension 118 118
Pneumothorax 114 114
Purulent Discharge 114 114
Undesired Nerve Stimulation 107 107
Tachycardia 107 107
Emotional Changes 103 103
Patient Problem/Medical Problem 100 100
Syncope/Fainting 100 100
Thrombosis 97 97
Heart Failure 83 83
Weakness 79 79
Inflammation 73 73
Non specific EKG/ECG Changes 72 72
Failure of Implant 69 69
Impaired Healing 64 64
Nausea 64 64
Hypersensitivity/Allergic reaction 60 60
Septic Shock 60 60
Fainting 57 57
Congestive Heart Failure 54 54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 53 53
Pleural Effusion 52 52
Post Operative Wound Infection 48 48
Thrombus 46 46
Erythema 45 45
Exit Block 44 44
Discharge 43 43
Shock 43 43
Atrial Tachycardia 42 42
Vomiting 40 40
Stroke/CVA 40 40
Chills 39 39
Cardiomyopathy 37 37
Perforation of Vessels 36 36
Loss of consciousness 36 36
Vascular Dissection 36 36
Cardiogenic Shock 34 34
Seizures 32 32
Edema 32 32
Myocardial Infarction 32 32
Abscess 32 32
Atrial Flutter 31 31
Fluid Discharge 30 30
Complete Heart Block 30 30
Hemorrhage/Bleeding 30 30
Burning Sensation 29 29
Injury 29 29
Stenosis 28 28
Necrosis 28 28
Pneumonia 27 27
Electro-Mechanical Dissociation 27 27

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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