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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 46

MDR Year MDR Reports MDR Events
2016 16636 16636
2017 18454 18454
2018 17238 17238
2019 16188 16188
2020 16914 16914
2021 8744 8744

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 22045 22045
Adverse Event Without Identified Device or Use Problem 19961 19961
High impedance 16802 16802
Inappropriate/Inadequate Shock/Stimulation 10012 10012
Signal Artifact/Noise 8325 8325
Fracture 7791 7791
Premature Discharge of Battery 6591 6591
Impedance Problem 5118 5118
High Capture Threshold 4930 4930
Device Sensing Problem 3784 3784
Device Displays Incorrect Message 2804 2804
Under-Sensing 2618 2618
Low impedance 2489 2489
Pacing Problem 2472 2472
Device Dislodged or Dislocated 2291 2291
Failure to Capture 2214 2214
Battery Problem 2096 2096
Capturing Problem 2089 2089
Ambient Noise Problem 2080 2080
Device Operates Differently Than Expected 1761 1761
Inappropriate or Unexpected Reset 1509 1509
Decreased Sensitivity 1330 1330
Mechanical Problem 1134 1134
Failure to Interrogate 1129 1129
Break 1115 1115
Material Integrity Problem 1010 1010
Failure to Read Input Signal 975 975
Appropriate Term/Code Not Available 957 957
Electrical /Electronic Property Problem 956 956
Defective Device 941 941
Positioning Failure 920 920
Invalid Sensing 910 910
Connection Problem 873 873
Defibrillation/Stimulation Problem 822 822
Device Alarm System 809 809
Failure to Convert Rhythm 779 779
Delayed Charge Time 661 661
Communication or Transmission Problem 656 656
Activation, Positioning or SeparationProblem 651 651
Premature Elective Replacement Indicator 650 650
Electromagnetic Interference 604 604
Positioning Problem 540 540
Nonstandard Device 510 510
Data Problem 455 455
Unstable Capture Threshold 444 444
Migration or Expulsion of Device 332 332
Failure to Select Signal 323 323
Noise, Audible 321 321
Incorrect, Inadequate or Imprecise Resultor Readings 315 315
Premature End-of-Life Indicator 306 306
Failure to Charge 304 304
Protective Measures Problem 251 251
Reset Problem 244 244
Interrogation Problem 221 221
Difficult to Remove 210 210
Migration 201 201
Intermittent Capture 199 199
Misconnection 197 197
Output Problem 196 196
Insufficient Information 183 183
Patient-Device Incompatibility 181 181
Unable to Obtain Readings 177 177
Failure to Deliver Shock/Stimulation 173 173
Incorrect Interpretation of Signal 170 170
Loose or Intermittent Connection 169 169
Failure to Sense 154 154
Inaccurate Synchronization 149 149
Unexpected Therapeutic Results 145 145
No Apparent Adverse Event 143 143
Telemetry Discrepancy 140 140
Human-Device Interface Problem 137 137
Incorrect Measurement 130 130
Pacemaker Found in Back-Up Mode 123 123
Charging Problem 96 96
Device-Device Incompatibility 95 95
Use of Device Problem 90 90
Pocket Stimulation 87 87
Collapse 79 79
Difficult to Interrogate 69 69
Difficult to Insert 65 65
Programming Issue 63 63
Wireless Communication Problem 63 63
Fitting Problem 61 61
No Audible Alarm 60 60
Device Contamination with Body Fluid 59 59
Unintended Electrical Shock 57 57
No Pacing 51 51
Material Deformation 50 50
Material Twisted/Bent 50 50
Missing Test Results 49 49
Off-Label Use 48 48
High Sensing Threshold 47 47
Low Sensing Threshold 44 44
Bent 44 44
Power Problem 43 43
Device Damaged by Another Device 42 42
Stretched 42 42
False Alarm 40 40
Arcing 37 37
Vibration 35 35

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 48283 48284
Unspecified Infection 10607 10607
No Consequences Or Impact To Patient 10499 10499
No Clinical Signs, Symptoms or Conditions 6150 6150
Shock from Patient Lead(s) 5501 5501
No Code Available 3750 3750
Sepsis 1903 1903
Death 1647 1648
Electric Shock 1556 1556
Syncope 955 955
Pocket Erosion 804 804
Ventricular Tachycardia 777 777
No Patient Involvement 720 720
Pain 693 693
Ventricular Fibrillation 676 676
Therapeutic Effects, Unexpected 656 656
Erosion 646 646
Insufficient Information 588 588
Hematoma 542 542
Complaint, Ill-Defined 539 539
Dizziness 503 503
Endocarditis 479 479
Cardiac Arrest 412 412
Cardiac Perforation 397 397
Dyspnea 369 369
Chest Pain 354 354
Discomfort 346 346
Device Overstimulation of Tissue 346 346
Twiddlers Syndrome 341 341
Bradycardia 316 316
Atrial Fibrillation 314 314
Pericardial Effusion 300 300
Muscle Stimulation 271 271
Arrhythmia 260 260
Wound Dehiscence 247 247
Swelling 232 232
Staphylococcus Aureus 215 215
Anxiety 214 214
Fall 211 211
No Information 209 209
Fever 199 199
Bacterial Infection 189 189
Occlusion 164 164
Perforation 160 160
Distress 154 154
Cardiac Tamponade 151 151
Palpitations 145 145
Depression 142 142
Fatigue 140 140
Low Blood Pressure/ Hypotension 119 119
Pneumothorax 114 114
Tachycardia 114 114
Purulent Discharge 114 114
Syncope/Fainting 110 110
Undesired Nerve Stimulation 109 109
Emotional Changes 103 103
Patient Problem/Medical Problem 100 100
Thrombosis 97 97
Heart Failure 83 83
Weakness 79 79
Inflammation 75 75
Non specific EKG/ECG Changes 73 73
Failure of Implant 69 69
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 65 65
Impaired Healing 64 64
Nausea 64 64
Septic Shock 62 62
Hypersensitivity/Allergic reaction 61 61
Fainting 57 57
Congestive Heart Failure 54 54
Pleural Effusion 52 52
Post Operative Wound Infection 48 48
Erythema 46 46
Thrombus 46 46
Exit Block 44 44
Discharge 43 43
Shock 43 43
Atrial Tachycardia 42 42
Vomiting 40 40
Stroke/CVA 40 40
Chills 39 39
Perforation of Vessels 37 37
Loss of consciousness 37 37
Vascular Dissection 37 37
Cardiomyopathy 37 37
Cardiogenic Shock 34 34
Seizures 32 32
Edema 32 32
Myocardial Infarction 32 32
Abscess 32 32
Fluid Discharge 32 32
Twiddlers Syndrome 32 32
Atrial Flutter 31 31
Obstruction/Occlusion 31 31
Hemorrhage/Bleeding 30 30
Complete Heart Block 30 30
Injury 29 29
Burning Sensation 29 29
Stenosis 28 28
Necrosis 28 28

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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