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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 0

MDR Year MDR Reports MDR Events
2020 17859 17859
2021 18441 18441
2022 19444 19444
2023 34550 34550
2024 25689 25689
2025 4311 4311

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 31651 31651
Adverse Event Without Identified Device or Use Problem 20454 20454
Over-Sensing 19164 19164
High Capture Threshold 16964 16964
High impedance 10209 10209
Device Dislodged or Dislocated 9377 9377
Failure to Capture 8363 8363
Signal Artifact/Noise 8089 8089
Impedance Problem 6020 6020
Pacing Problem 5665 5665
Fracture 5129 5129
Decreased Sensitivity 4697 4697
Low impedance 4669 4669
Electrical /Electronic Property Problem 4330 4330
Capturing Problem 4160 4160
Positioning Problem 3448 3448
Break 2067 2067
Unstable Capture Threshold 1985 1985
Appropriate Term/Code Not Available 1971 1971
Activation, Positioning or Separation Problem 1681 1681
Device Sensing Problem 1653 1653
Insufficient Information 1309 1309
Intermittent Capture 1189 1189
Material Integrity Problem 1139 1139
Defective Device 767 767
Positioning Failure 559 559
Therapeutic or Diagnostic Output Failure 381 381
No Apparent Adverse Event 365 365
Mechanical Problem 339 339
Material Twisted/Bent 267 267
Inappropriate/Inadequate Shock/Stimulation 207 207
Failure to Read Input Signal 179 179
Electromagnetic Interference 179 179
Difficult to Remove 167 167
Connection Problem 167 167
High Sensing Threshold 160 160
Collapse 151 151
Pocket Stimulation 150 150
Device-Device Incompatibility 137 137
Use of Device Problem 133 133
Premature Activation 127 127
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 76 76
Failure to Sense 69 69
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 71523 71523
Unspecified Infection 15461 15461
No Consequences Or Impact To Patient 5916 5916
Insufficient Information 4523 4523
No Known Impact Or Consequence To Patient 4370 4370
Chest Pain 1951 1951
Dizziness 1751 1751
Bradycardia 1654 1654
Dyspnea 1627 1627
Syncope/Fainting 1613 1613
Sepsis 1429 1429
Arrhythmia 1281 1281
Bacterial Infection 1214 1214
Pocket Erosion 1197 1197
Cardiac Perforation 1177 1177
No Code Available 1148 1148
Pericardial Effusion 1072 1072
Discomfort 951 951
Erythema 887 887
Erosion 845 845
Pain 820 820
Tachycardia 781 781
Fall 710 710
Endocarditis 665 665
Device Overstimulation of Tissue 663 663
Swelling/ Edema 663 663
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 605 605
Fever 558 558
Atrial Fibrillation 555 555
Purulent Discharge 552 552
Obstruction/Occlusion 551 551
Cardiac Arrest 515 515
Wound Dehiscence 445 445
Undesired Nerve Stimulation 442 442
Heart Block 414 414
Perforation 403 403
Cardiac Tamponade 390 390
Fatigue 381 381
Muscle Weakness 379 379
Asystole 366 366
Non specific EKG/ECG Changes 351 351
Low Blood Pressure/ Hypotension 350 350
Presyncope 344 344
Foreign Body In Patient 313 313
Hematoma 305 305
Twiddlers Syndrome 299 299
Shock from Patient Lead(s) 273 273
Failure of Implant 233 233
Syncope 232 232
Drug Resistant Bacterial Infection 229 229

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