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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pacemaker lead adaptor
Regulation Description Pacemaker lead adaptor.
Product CodeDTD
Regulation Number 870.3620
Device Class 2

MDR Year MDR Reports MDR Events
2021 23 23
2022 25 26
2023 28 29
2024 35 35
2025 32 32
2026 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 73 73
Over-Sensing 11 11
High Capture Threshold 10 10
High impedance 7 7
Failure to Capture 6 6
Signal Artifact/Noise 6 6
Ambient Noise Problem 5 5
Low impedance 5 5
Device Sensing Problem 5 5
Insufficient Device Problem Information 4 4
Capturing Problem 4 4
Degraded 4 4
Break 3 3
Use of Device Problem 3 3
Appropriate Device Problem Term/Code Not Available 3 3
Off-Label Use 2 2
Connection Problem 2 2
Pacing Problem 2 2
No Apparent Adverse Event 2 2
Mechanical Jam 1 1
Fracture 1 1
Noise, Audible 1 1
Premature Discharge of Battery 1 2
Under-Sensing 1 1
Extracardiac stimulation 1 1
Impedance Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Separation 1 1
Failure to Sense 1 1
Detachment of Device or Device Component 1 1
High Sensing Threshold 1 1
Loose or Intermittent Connection 1 1
Battery Problem 1 1
Device Alarm System 1 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 60 60
No Clinical Signs, Symptoms or Conditions 58 60
Insufficient Information 10 10
Failure of Implant 6 6
Discomfort 5 5
Bacteremia 4 4
Swelling/ Edema 4 4
Pocket Erosion 4 4
Fever 4 4
Endocarditis 4 4
Erythema 4 4
Sepsis 3 3
Bacterial Infection 3 3
Purulent Discharge 3 3
Medical device site infection 3 3
Dizziness 3 3
Arrhythmia 2 2
Erosion 2 2
Bradycardia 2 2
Wound Dehiscence 2 2
Fluid Discharge 2 2
Pain 2 2
Cardiac Perforation 1 1
Congenital Defect/Deformity 1 1
Chills 1 1
Cardiac Tamponade 1 1
Heart Failure/Congestive Heart Failure 1 1
Skin Erosion 1 1
Heart Block 1 1
Device Embedded In Tissue or Plaque 1 1
Pericardial Effusion 1 1
Respiratory Failure 1 1
Presyncope 1 1
Hematoma 1 1
Hypersensitivity/Allergic reaction 1 1

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