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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 25
2023 28 28
2024 35 35
2025 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 76 76
Over-Sensing 14 14
High Capture Threshold 12 12
Signal Artifact/Noise 9 9
High impedance 7 7
Failure to Capture 6 6
Insufficient Information 5 5
Ambient Noise Problem 5 5
Low impedance 5 5
Break 4 4
Degraded 4 4
Device Sensing Problem 4 4
Impedance Problem 3 3
Use of Device Problem 3 3
Appropriate Term/Code Not Available 3 3
Capturing Problem 3 3
Off-Label Use 2 2
Detachment of Device or Device Component 2 2
Pacing Problem 2 2
Under-Sensing 2 2
Connection Problem 2 2
Noise, Audible 2 2
Device Alarm System 1 1
Device Fell 1 1
Failure to Sense 1 1
Material Integrity Problem 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
No Apparent Adverse Event 1 1
Fracture 1 1
Pocket Stimulation 1 1
High Sensing Threshold 1 1
Premature Discharge of Battery 1 1
Loose or Intermittent Connection 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 67 67
No Clinical Signs, Symptoms or Conditions 54 54
Insufficient Information 9 9
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
Purulent Discharge 3 3
Wound Dehiscence 2 2
Arrhythmia 2 2
Dizziness 2 2
Hematoma 2 2
Pain 2 2
Bradycardia 2 2
Fluid Discharge 2 2
Bacterial Infection 2 2
Erosion 2 2
Hypersensitivity/Allergic reaction 1 1
No Information 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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