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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implantable pulse generator, pacemaker (non-crt)
Definition These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Product CodeLWP
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
116 97 88 90 70 2

MDR Year MDR Reports MDR Events
2017 11644 11644
2018 14934 14934
2019 9629 9629
2020 8988 8988
2021 9378 9378

Device Problems MDRs with this Device Problem Events in those MDRs
Premature Discharge of Battery 14339 14339
Adverse Event Without Identified Device or Use Problem 10171 10171
Device Displays Incorrect Message 7870 7870
High impedance 5769 5769
Over-Sensing 4478 4478
Pacing Problem 2941 2941
Failure to Capture 2926 2926
Ambient Noise Problem 2213 2213
Material Integrity Problem 2139 2139
Pacemaker Found in Back-Up Mode 2056 2056
Device Dislodged or Dislocated 1978 1978
Capturing Problem 1824 1824
Defective Device 1786 1786
Device Operates Differently Than Expected 1565 1565
Battery Problem 1529 1529
Device Sensing Problem 1468 1468
Signal Artifact/Noise 1206 1206
High Capture Threshold 1116 1116
Noise, Audible 1080 1080
Low impedance 1034 1034
Device Alarm System 924 924
Connection Problem 831 831
Under-Sensing 692 692
Failure to Interrogate 627 627
Impedance Problem 569 569
Inappropriate/Inadequate Shock/Stimulation 552 552
Incorrect, Inadequate or Imprecise Resultor Readings 491 491
Pocket Stimulation 483 483
Communication or Transmission Problem 420 420
Inappropriate or Unexpected Reset 417 417
Data Problem 395 395
Human-Device Interface Problem 390 390
Fracture 346 346
Incorrect Measurement 340 340
Use of Device Problem 333 333
Operating System Version or Upgrade Problem 316 316
Difficult To Position 276 276
Electrical /Electronic Property Problem 271 271
Mechanical Problem 267 267
Appropriate Term/Code Not Available 237 237
Telemetry Discrepancy 230 230
Output Problem 229 229
No Pacing 219 219
Interrogation Problem 207 207
No Device Output 199 199
No Display/Image 183 183
Positioning Problem 183 183
Difficult to Remove 174 174
Reset Problem 172 172
Break 160 160
Premature Elective Replacement Indicator 154 154
Off-Label Use 151 151
Migration 148 148
Difficult to Insert 136 136
Migration or Expulsion of Device 135 135
Misconnection 131 131
Failure to Sense 127 127
No Apparent Adverse Event 127 127
Loose or Intermittent Connection 114 114
Unexpected Therapeutic Results 104 104
Defibrillation/Stimulation Problem 103 103
Patient-Device Incompatibility 102 102
Wireless Communication Problem 95 95
Fitting Problem 93 93
Failure to Convert Rhythm 93 93
Unexpected Shutdown 88 88
Inaccurate Synchronization 83 83
Insufficient Information 78 78
Device Contamination with Chemical or Other Material 77 77
Power Problem 69 69
Calibration Problem 65 65
Failure to Read Input Signal 65 65
Display or Visual Feedback Problem 61 61
Device Contamination With Biological Material 61 61
Intermittent Capture 60 60
False Positive Result 59 59
Pacing Inadequately 57 57
Unable to Obtain Readings 55 55
Failure to Disconnect 54 54
Programming Issue 50 50
Failure to Select Signal 49 49
Pacing Asynchronously 49 49
Pacing Intermittently 43 43
Missing Test Results 43 43
Difficult to Interrogate 41 41
No Audible Alarm 39 39
Delayed Charge Time 38 38
Unintended Electrical Shock 38 38
Loss of Data 38 38
Unstable Capture Threshold 36 36
Battery Problem: High Impedance 35 35
Contamination /Decontamination Problem 32 32
Failure to Power Up 30 30
Electromagnetic Interference 27 27
Contamination 26 26
Premature End-of-Life Indicator 25 25
Separation Failure 25 25
Problem with Software Installation 25 25
Inadequate User Interface 25 25
Component Missing 22 22

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 21123 21123
No Consequences Or Impact To Patient 9759 9759
Unspecified Infection 7682 7682
No Clinical Signs, Symptoms or Conditions 6382 6382
No Code Available 4447 4447
Sepsis 2498 2498
Syncope 1177 1177
No Patient Involvement 1135 1135
Insufficient Information 1044 1044
Pocket Erosion 898 898
Death 706 706
Muscle Stimulation 683 683
Dizziness 603 603
Complaint, Ill-Defined 552 553
No Information 409 409
Bradycardia 375 375
Atrial Fibrillation 374 374
Erosion 314 314
Cardiac Perforation 284 284
Discomfort 259 259
Pain 256 256
Dyspnea 248 248
Electric Shock 240 240
Arrhythmia 236 236
Fatigue 216 216
Bacterial Infection 215 215
Endocarditis 204 204
Hematoma 194 194
Cardiac Arrest 182 182
Fall 181 181
Staphylococcus Aureus 180 180
Syncope/Fainting 167 167
Ventricular Tachycardia 165 165
Chest Pain 156 156
Ventricular Fibrillation 145 145
Twiddlers Syndrome 135 135
Pericardial Effusion 127 127
Palpitations 126 126
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 114 114
Undesired Nerve Stimulation 111 111
Device Overstimulation of Tissue 100 100
Fever 97 97
Swelling 96 96
Wound Dehiscence 84 84
Complete Heart Block 84 84
Heart Failure 81 81
Purulent Discharge 71 71
Anxiety 69 69
Tachycardia 68 68
Asystole 64 64
Low Blood Pressure/ Hypotension 62 62
Inflammation 60 60
Patient Problem/Medical Problem 58 58
Atrial Flutter 49 49
Non specific EKG/ECG Changes 48 48
Atrial Perforation 42 42
Hypersensitivity/Allergic reaction 39 39
Atrial Tachycardia 38 38
Weakness 38 38
Post Operative Wound Infection 37 37
Fainting 34 34
Cardiac Tamponade 33 33
Nausea 31 31
Pneumothorax 31 31
Vascular Dissection 30 30
Discharge 29 29
Occlusion 28 28
Cardiopulmonary Arrest 28 28
Congestive Heart Failure 25 25
Pneumonia 25 25
Seizures 24 24
Stroke/CVA 24 24
Head Injury 24 24
Hemorrhage/Bleeding 24 24
Thrombosis 23 23
Pleural Effusion 22 22
Abscess 22 22
High Blood Pressure/ Hypertension 21 21
Perforation of Vessels 21 21
Fluid Discharge 21 21
Exit Block 20 20
Septic Shock 19 19
Perforation 19 19
Cardiomyopathy 19 19
Loss of consciousness 18 18
Swelling/ Edema 17 17
Myocardial Infarction 16 16
Edema 15 15
Presyncope 15 15
Injury 15 15
Respiratory Failure 15 15
Unspecified Heart Problem 14 14
Bone Fracture(s) 14 14
Bruise/Contusion 14 14
Necrosis 13 13
Burning Sensation 13 13
Lethargy 13 13
Malaise 13 13
Chest Tightness/Pressure 12 12
Loss Of Pulse 11 11

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation I Jul-13-2021
2 Boston Scientific Corporation II Jul-02-2021
3 Boston Scientific Corporation II Jan-15-2018
4 St Jude Medical Inc. II Jun-12-2018
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