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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)
2020 2021 2022 2023 2024 2025
90 70 65 54 58 13

MDR Year MDR Reports MDR Events
2020 8989 8989
2021 9374 9374
2022 14287 14287
2023 12638 12638
2024 10500 10501
2025 2601 2601

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 15894 15895
Premature Discharge of Battery 13881 13881
Over-Sensing 5431 5431
Battery Problem 4378 4378
Incorrect, Inadequate or Imprecise Result or Readings 4232 4232
Defective Device 3975 3975
High impedance 3929 3929
Pacing Problem 3527 3527
Signal Artifact/Noise 3286 3286
Failure to Capture 2677 2677
High Capture Threshold 1902 1902
Under-Sensing 1614 1614
Failure to Interrogate 1388 1388
Low impedance 801 801
Device Dislodged or Dislocated 791 791
Noise, Audible 691 691
Failure to Read Input Signal 679 679
Inappropriate/Inadequate Shock/Stimulation 669 669
No Pacing 659 659
Incorrect Measurement 622 622
Device Displays Incorrect Message 612 612
Pacemaker Found in Back-Up Mode 610 610
Interrogation Problem 607 607
Connection Problem 577 577
Material Integrity Problem 522 522
No Apparent Adverse Event 418 418
Device Sensing Problem 393 393
Data Problem 391 391
Impedance Problem 361 361
Telemetry Discrepancy 327 327
Loose or Intermittent Connection 284 284
Off-Label Use 231 231
Pocket Stimulation 229 229
Inappropriate or Unexpected Reset 219 219
Insufficient Information 213 213
Inaccurate Synchronization 205 205
Migration 202 202
Pacing Asynchronously 199 199
Capturing Problem 188 188
Use of Device Problem 180 180
Positioning Problem 157 157
Difficult to Insert 140 140
Failure to Disconnect 135 135
Appropriate Term/Code Not Available 134 134
Unexpected Therapeutic Results 128 128
Fracture 119 119
Difficult to Remove 118 118
Mechanical Problem 113 113
Output Problem 112 112
Communication or Transmission Problem 108 108

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 35893 35893
Unspecified Infection 7189 7190
No Code Available 4264 4264
No Known Impact Or Consequence To Patient 3751 3751
Insufficient Information 2696 2696
No Consequences Or Impact To Patient 1653 1653
Sepsis 1218 1218
Pocket Erosion 1005 1005
Syncope/Fainting 990 990
Arrhythmia 740 740
Asystole 645 645
Dizziness 606 606
Discomfort 603 603
Electric Shock 537 537
Device Overstimulation of Tissue 520 520
Bradycardia 447 447
Bacterial Infection 321 321
Dyspnea 282 282
Fatigue 226 226
Pain 207 207
Hematoma 195 195
Shock from Patient Lead(s) 188 188
No Patient Involvement 184 184
Erosion 174 174
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 166 166
Wound Dehiscence 160 160
Fall 157 157
Unspecified Heart Problem 152 152
Syncope 133 133
Endocarditis 129 129
Atrial Fibrillation 128 128
Muscle Stimulation 116 116
Presyncope 113 113
Swelling/ Edema 105 105
Death 100 100
Chest Pain 95 95
No Information 93 93
Cardiac Arrest 89 89
Undesired Nerve Stimulation 88 88
Anxiety 87 87
Ventricular Fibrillation 87 87
Loss of consciousness 87 87
Tachycardia 78 78
Fever 72 72
Purulent Discharge 64 64
Malaise 58 58
Hypersensitivity/Allergic reaction 54 54
Heart Failure/Congestive Heart Failure 52 52
Twiddlers Syndrome 46 46
Low Blood Pressure/ Hypotension 46 46

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation I Jan-10-2025
2 Boston Scientific Corporation I Jul-13-2021
3 Boston Scientific Corporation II Jul-02-2021
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