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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device permanent pacemaker electrode
Regulation Description Cardiovascular permanent or temporary pacemaker electrode.
Product CodeDTB
Regulation Number 870.3680
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
6 3 4 7 3 1

MDR Year MDR Reports MDR Events
2020 17859 17859
2021 18441 18441
2022 19444 19444
2023 34550 34550
2024 25690 25690
2025 6405 6405

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 32248 32248
Adverse Event Without Identified Device or Use Problem 20810 20810
Over-Sensing 19511 19511
High Capture Threshold 17273 17273
High impedance 10400 10400
Device Dislodged or Dislocated 9513 9513
Failure to Capture 8518 8518
Signal Artifact/Noise 8249 8249
Impedance Problem 6148 6148
Pacing Problem 5894 5894
Fracture 5241 5241
Decreased Sensitivity 4810 4810
Low impedance 4761 4761
Electrical /Electronic Property Problem 4423 4423
Capturing Problem 4226 4226
Positioning Problem 3490 3490
Break 2094 2094
Unstable Capture Threshold 2013 2013
Appropriate Term/Code Not Available 2002 2002
Activation, Positioning or Separation Problem 1709 1709
Device Sensing Problem 1677 1677
Insufficient Information 1318 1318
Intermittent Capture 1219 1219
Material Integrity Problem 1150 1150
Defective Device 786 786
Positioning Failure 567 567
Therapeutic or Diagnostic Output Failure 381 381
No Apparent Adverse Event 365 365
Mechanical Problem 348 348
Material Twisted/Bent 277 277
Inappropriate/Inadequate Shock/Stimulation 210 210
Electromagnetic Interference 181 181
Failure to Read Input Signal 180 180
Connection Problem 170 170
Difficult to Remove 169 169
High Sensing Threshold 160 160
Collapse 153 153
Pocket Stimulation 150 150
Device-Device Incompatibility 139 139
Use of Device Problem 133 133
Premature Activation 130 130
Ambient Noise Problem 110 110
Product Quality Problem 100 100
Pacemaker Found in Back-Up Mode 91 91
Device Contamination with Body Fluid 83 83
No Pacing 83 83
Off-Label Use 78 78
Failure to Sense 70 70
Material Split, Cut or Torn 62 62
Degraded 60 60

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 73061 73061
Unspecified Infection 15704 15704
No Consequences Or Impact To Patient 5916 5916
Insufficient Information 4543 4543
No Known Impact Or Consequence To Patient 4370 4370
Chest Pain 1982 1982
Dizziness 1780 1780
Bradycardia 1681 1681
Dyspnea 1661 1661
Syncope/Fainting 1645 1645
Sepsis 1448 1448
Arrhythmia 1304 1304
Bacterial Infection 1241 1241
Pocket Erosion 1210 1210
Cardiac Perforation 1189 1189
No Code Available 1148 1148
Pericardial Effusion 1089 1089
Discomfort 983 983
Erythema 921 921
Erosion 873 873
Pain 841 841
Tachycardia 795 795
Fall 722 722
Swelling/ Edema 686 686
Device Overstimulation of Tissue 678 678
Endocarditis 673 673
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 614 614
Purulent Discharge 586 586
Fever 568 568
Atrial Fibrillation 564 564
Obstruction/Occlusion 561 561
Cardiac Arrest 517 517
Wound Dehiscence 456 456
Undesired Nerve Stimulation 443 443
Heart Block 418 418
Perforation 408 408
Cardiac Tamponade 397 397
Muscle Weakness 384 384
Fatigue 384 384
Asystole 378 378
Presyncope 358 358
Low Blood Pressure/ Hypotension 356 356
Non specific EKG/ECG Changes 355 355
Hematoma 315 315
Foreign Body In Patient 313 313
Twiddlers Syndrome 310 310
Shock from Patient Lead(s) 280 280
Drug Resistant Bacterial Infection 244 244
Failure of Implant 237 237
Syncope 232 232

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