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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
2020 19 19
2021 23 23
2022 25 26
2023 28 29
2024 35 35
2025 32 32
2026 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 83 83
Over-Sensing 15 15
High Capture Threshold 12 12
Signal Artifact/Noise 9 9
High impedance 8 8
Failure to Capture 6 6
Ambient Noise Problem 6 6
Low impedance 6 6
Insufficient Information 5 5
Device Sensing Problem 5 5
Capturing Problem 5 5
Break 4 4
Degraded 4 4
Impedance Problem 3 3
Use of Device Problem 3 3
Pacing Problem 3 3
Under-Sensing 3 3
Appropriate Term/Code Not Available 3 3
Off-Label Use 2 2
Material Integrity Problem 2 2
Detachment of Device or Device Component 2 2
No Apparent Adverse Event 2 2
Connection Problem 2 2
Noise, Audible 2 2
Device Alarm System 1 2
Device Fell 1 1
Failure to Sense 1 1
Defective Component 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient Device Interaction Problem 1 1
Intermittent Capture 1 1
Battery Problem 1 1
Unstable Capture Threshold 1 1
Material Separation 1 1
Fracture 1 1
Pocket Stimulation 1 1
High Sensing Threshold 1 1
Premature Discharge of Battery 1 2
Loose or Intermittent Connection 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 68 68
No Clinical Signs, Symptoms or Conditions 60 62
Insufficient Information 10 10
Failure of Implant 6 6
No Known Impact Or Consequence To Patient 5 5
Discomfort 5 5
Fever 4 4
Erythema 4 4
Swelling/ Edema 4 4
Endocarditis 4 4
No Consequences Or Impact To Patient 4 4
Pocket Erosion 4 4
Sepsis 3 3
Dizziness 3 3
Purulent Discharge 3 3
Bacterial Infection 3 3
Erosion 3 3
Wound Dehiscence 2 2
Arrhythmia 2 2
Hematoma 2 2
Pain 2 2
Bradycardia 2 2
Fluid Discharge 2 2
Hypersensitivity/Allergic reaction 1 1
No Information 1 1
Presyncope 1 1
Head Injury 1 1
Pericardial Effusion 1 1
Cardiac Tamponade 1 1
Skin Erosion 1 1
Burning Sensation 1 1
Chills 1 1
Cardiac Perforation 1 1
Chest Pain 1 1
Skin Inflammation 1 1
Congenital Defect/Deformity 1 1
Heart Failure/Congestive Heart Failure 1 1
Heart Block 1 1
Respiratory Failure 1 1
Device Embedded In Tissue or Plaque 1 1

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