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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 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 61 61
Over-Sensing 12 12
High impedance 11 11
Signal Artifact/Noise 8 8
Ambient Noise Problem 7 7
High Capture Threshold 7 7
Failure to Capture 6 6
Impedance Problem 5 5
Connection Problem 4 4
Low impedance 4 4
Break 4 4
Fracture 3 3
Use of Device Problem 3 3
Capturing Problem 3 3
Device Sensing Problem 3 3
Material Integrity Problem 2 2
Under-Sensing 2 2
Detachment of Device or Device Component 2 2
Off-Label Use 2 2
Noise, Audible 2 2
Device Fell 1 1
Unstable Capture Threshold 1 1
Retraction Problem 1 1
Failure to Sense 1 1
Material Separation 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Pacing Problem 1 1
Pocket Stimulation 1 1
Device Alarm System 1 1
Difficult or Delayed Positioning 1 1
Intermittent Capture 1 1
Premature Discharge of Battery 1 1
Battery Problem 1 1
High Sensing Threshold 1 1
Mechanical Jam 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 49 49
No Clinical Signs, Symptoms or Conditions 34 34
No Known Impact Or Consequence To Patient 22 22
Insufficient Information 7 7
Erosion 5 5
Sepsis 5 5
No Consequences Or Impact To Patient 5 5
Pocket Erosion 4 4
Failure of Implant 3 3
Fluid Discharge 2 2
Endocarditis 2 2
Therapeutic Response, Decreased 2 2
Skin Inflammation 1 1
Respiratory Failure 1 1
Cardiac Perforation 1 1
Cardiac Tamponade 1 1
Skin Erosion 1 1
Burning Sensation 1 1
Head Injury 1 1
Hematoma 1 1
Chest Pain 1 1
Death 1 1
Wound Dehiscence 1 1
Arrhythmia 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Pericardial Effusion 1 1
Heart Block 1 1
Heart Failure/Congestive Heart Failure 1 1

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