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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
Product CodeDTD
Regulation Number 870.3620
Device Class 2

MDR Year MDR Reports MDR Events
2019 34 34
2020 19 19
2021 23 23
2022 25 25
2023 28 28
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 68 68
High impedance 13 13
Over-Sensing 13 13
Signal Artifact/Noise 10 10
High Capture Threshold 10 10
Failure to Capture 8 8
Ambient Noise Problem 7 7
Impedance Problem 5 5
Break 4 4
Device Sensing Problem 4 4
Connection Problem 4 4
Low impedance 4 4
Insufficient Information 3 3
Capturing Problem 3 3
Use of Device Problem 3 3
Fracture 3 3
Off-Label Use 2 2
Detachment of Device or Device Component 2 2
Material Integrity Problem 2 2
Under-Sensing 2 2
Pacing Problem 2 2
Noise, Audible 2 2
Mechanical Problem 1 1
Device Alarm System 1 1
Device Fell 1 1
Intermittent Capture 1 1
Battery Problem 1 1
Retraction Problem 1 1
No Apparent Adverse Event 1 1
Material Separation 1 1
Pocket Stimulation 1 1
Mechanical Jam 1 1
Loose or Intermittent Connection 1 1
Premature Discharge of Battery 1 1
Therapeutic or Diagnostic Output Failure 1 1
Failure to Sense 1 1
Difficult or Delayed Positioning 1 1
Unstable Capture Threshold 1 1
High Sensing Threshold 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 55 55
No Clinical Signs, Symptoms or Conditions 41 41
No Known Impact Or Consequence To Patient 22 22
Insufficient Information 7 7
Sepsis 5 5
No Consequences Or Impact To Patient 5 5
Erosion 5 5
Pocket Erosion 5 5
Failure of Implant 3 3
Arrhythmia 2 2
Dizziness 2 2
Fluid Discharge 2 2
Bradycardia 2 2
Therapeutic Response, Decreased 2 2
Endocarditis 2 2
Death 1 1
Wound Dehiscence 1 1
Hypersensitivity/Allergic reaction 1 1
No Information 1 1
Head Injury 1 1
Hematoma 1 1
Pericardial Effusion 1 1
Cardiac Tamponade 1 1
Burning Sensation 1 1
Cardiac Perforation 1 1
Skin Erosion 1 1
Fever 1 1
Chills 1 1
Chest Pain 1 1
Skin Inflammation 1 1
Discomfort 1 1
Heart Failure/Congestive Heart Failure 1 1
Congenital Defect/Deformity 1 1
Heart Block 1 1
Respiratory Failure 1 1
Device Embedded In Tissue or Plaque 1 1

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