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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
Product CodeDTB
Regulation Number 870.3680
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023 2024
6 7 6 3 4 7 3

MDR Year MDR Reports MDR Events
2018 15208 15216
2019 16812 16812
2020 17859 17859
2021 18441 18441
2022 19444 19444
2023 34550 34550
2024 23752 23752

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 35837 35837
Adverse Event Without Identified Device or Use Problem 24441 24449
Over-Sensing 23250 23250
High Capture Threshold 21706 21706
High impedance 13245 13245
Device Dislodged or Dislocated 13242 13242
Failure to Capture 10921 10921
Signal Artifact/Noise 9510 9510
Impedance Problem 7225 7225
Fracture 6623 6623
Pacing Problem 6270 6270
Low impedance 5902 5902
Capturing Problem 5658 5658
Decreased Sensitivity 5469 5469
Electrical /Electronic Property Problem 4646 4646
Positioning Problem 4503 4503
Unstable Capture Threshold 2683 2683
Break 2680 2680
Device Sensing Problem 2493 2493
Activation, Positioning or Separation Problem 2459 2459
Appropriate Term/Code Not Available 2442 2442
Material Integrity Problem 1839 1839
Intermittent Capture 1591 1591
Insufficient Information 1442 1442
Defective Device 936 936
Positioning Failure 771 771
Mechanical Problem 437 437
Ambient Noise Problem 435 435
Therapeutic or Diagnostic Output Failure 381 381
No Apparent Adverse Event 376 376
Failure to Sense 361 361
Material Twisted/Bent 361 361
High Sensing Threshold 315 315
Connection Problem 270 270
Pocket Stimulation 265 265
Difficult to Remove 256 256
Inappropriate/Inadequate Shock/Stimulation 255 255
Electromagnetic Interference 225 225
Collapse 209 209
Device Operates Differently Than Expected 183 183
Premature Activation 183 183
Device-Device Incompatibility 176 176
Failure to Read Input Signal 165 165
Use of Device Problem 145 145
Electronic Property Issue 127 127
Degraded 114 114
Device Contamination with Body Fluid 109 109
Product Quality Problem 101 101
No Pacing 100 100
Pacemaker Found in Back-Up Mode 92 92

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 67147 67147
No Known Impact Or Consequence To Patient 26588 26589
Unspecified Infection 18224 18232
No Consequences Or Impact To Patient 6936 6936
Insufficient Information 4480 4480
Chest Pain 2234 2234
Dizziness 2217 2217
Sepsis 2029 2029
Bradycardia 1985 1985
Dyspnea 1930 1930
Cardiac Perforation 1720 1720
Syncope/Fainting 1543 1543
Pericardial Effusion 1436 1436
No Code Available 1434 1434
Pocket Erosion 1385 1393
Arrhythmia 1311 1311
Bacterial Infection 1204 1204
Discomfort 967 967
Pain 952 952
Erosion 941 941
Endocarditis 862 862
Syncope 847 847
Fall 823 823
Tachycardia 800 800
Erythema 794 794
Undesired Nerve Stimulation 690 690
Cardiac Arrest 678 678
Device Overstimulation of Tissue 663 663
Atrial Fibrillation 626 626
Muscle Stimulation 588 588
Swelling/ Edema 583 583
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 583 583
Fever 565 565
Cardiac Tamponade 551 551
Obstruction/Occlusion 525 525
Purulent Discharge 509 509
Perforation 492 492
Wound Dehiscence 487 487
Fatigue 475 475
Death 472 472
Non specific EKG/ECG Changes 437 437
Low Blood Pressure/ Hypotension 418 418
Heart Block 401 401
Hematoma 378 378
Muscle Weakness 367 367
Asystole 348 348
Shock from Patient Lead(s) 323 323
Foreign Body In Patient 314 314
Palpitations 312 312
Presyncope 305 305

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